xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05985980</url>
    </required_header>
    <id_info>
      <org_study_id>2023/0129</org_study_id>
      <nct_id>NCT05985980</nct_id>
    </id_info>
    <brief_title>The Effect of Menstrual Cycle on the Results of Treadmill Exercise Test With High Sensitive Cardiac Troponin Levels After Exercise in Women</brief_title>
    <official_title>The Effect of Menstrual Cycle on the Results of Treadmill Exercise Test With High Sensitive Cardiac Troponin Levels After Exercise in Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medeniyet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medeniyet University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        False positive results are commonly observed in women after exercise treadmill test (ETT).&#xD;
        The effects of menstrual periodic changes on the results of exercise treadmill test in&#xD;
        premenopausal women have not been clearly defined. Primary purpose of the study is to&#xD;
        investigate the biological causes of false positive test results in the treadmill exercise&#xD;
        test in premenopausal women. Estrogen is known to have direct vasodilatory effects on&#xD;
        coronary arteries. Early and late follicular phases of the menstrual cycle are characterized&#xD;
        by low and high estrogen levels, respectively. The Early Follicular Phase starts on the first&#xD;
        day of the menstrual cycle and ends when oestradiol begins to increase. It is characterised&#xD;
        by increasing LH and FSH and constant low levels of oestradiol. The late follicular phase&#xD;
        starts with the increase in oestradiol and ends at its preovulatory peak. The hypothesis of&#xD;
        the study is that ETT results will change at the early and late follicular phases in&#xD;
        premenstrual women. Premenopausal women between the ages of 18-40, who apply to the&#xD;
        cardiology outpatient clinics of Göztepe City Hospital with typical/atypical chest pain, and&#xD;
        an indication for ETT will be included in the study. ETT will be performed in the early and&#xD;
        late follicular phases of the menstrual cycle, separately.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Estrogen is known to have direct vasodilatory effects on coronary arteries. Early and late&#xD;
        follicular phases of the menstrual cycle in premenopausal women are characterized by low and&#xD;
        high estrogen levels, respectively. The Early Follicular Phase starts on the first day of the&#xD;
        menstrual cycle and ends when oestradiol begins to increase. It is characterised by&#xD;
        increasing LH and FSH and constant low levels of oestradiol. The late follicular phase starts&#xD;
        with the increase in oestradiol and ends at its preovulatory peak. Premenopausal women&#xD;
        (between the ages of 18-40), who apply to the cardiology outpatient clinics of Göztepe City&#xD;
        Hospital with typical/atypical chest pain, and an indication for exercise treadmill test&#xD;
        (ETT) will be included in the study. ETT will be performed in the early and late follicular&#xD;
        phases of the menstrual cycle, separately.&#xD;
  &#xD;
        Forty (40) patients who meet these conditions will be included in the study.&#xD;
  &#xD;
        The menstrual cycle of the patient will be questioned in the screening interview.&#xD;
        Premenopausal female patients between the ages of 18-40 who still have a regular menstrual&#xD;
        cycles will be included in the study. Hormone levels including Estradiol III, follicle&#xD;
        stimulating hormone (FSH), luteinizing hormone (LH), progesterone (Elecsys) will be measured&#xD;
        to confirm the menstrual cycle before each ETT. ETT will be performed in the early and late&#xD;
        follicular phases of the menstrual cycle, separately. Cardiac high sensitive troponin I (hs&#xD;
        cTnI) (Roche) will be measured before and after ETT.&#xD;
  &#xD;
        Primary end point will the ST/HR (heart rate) index (μV/bpm) in ETT. The ST/HR index (μV/bpm)&#xD;
        is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill &amp; CASE&#xD;
        6.73 Stress Test System.&#xD;
  &#xD;
        The secondary endpoints will be the change in hs cTnI between the before and after ETT,&#xD;
        maximal exercise capacity (METs score), ST/HR slope (μV/bpm), maximal horizontal or down&#xD;
        slope ST segment depression (mm) with exercise. Secondary end points other than cTnI are&#xD;
        automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill &amp; CASE&#xD;
        6.73 Stress Test System.&#xD;
  &#xD;
        The null hypothesis is that there is no difference between in the ST/HR index (μV/bpm)&#xD;
        between the menstrual phases. The power is calculated to prove the alternative hypothesis in&#xD;
        which there is a 50 % difference between the ETT ST/HR index (μV/bpm). In a paired study&#xD;
        sample, with type I error of 5 % and type II error of 20 %, the sample size is calculated as&#xD;
        34 patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>ST/HR index (μV/bpm) in ETT.</measure>
      <time_frame>March-September 2023</time_frame>
      <description>The ST/HR index (μV/bpm) is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill &amp; CASE 6.73 Stress Test System.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change in the concentrations of high sensitive cardiac troponin I (ng/L) change before and after exercise</measure>
      <time_frame>May-September 2023</time_frame>
      <description>hs cTnI will be measured by Roche kit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>maximal exercise capacity (METs score)</measure>
      <time_frame>May-September 2023</time_frame>
      <description>automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill &amp; CASE 6.73 Stress Test System.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ST/HR slope (μV/bpm)</measure>
      <time_frame>May-September 2023</time_frame>
      <description>automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill &amp; CASE 6.73 Stress Test System.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>maximal horizontal or down slope ST segment depression (mm) with exercise</measure>
      <time_frame>May-September 2023</time_frame>
      <description>automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill &amp; CASE 6.73 Stress Test System.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Menstrual Cycle Disorder</condition>
    <condition>Exercise Induced Ischemia</condition>
    <arm_group>
      <arm_group_label>Exercise test results will be grouped based on the menstrual cycle.</arm_group_label>
      <description>Positive exercise treadmill tests will be repeated at a different phase of menstrual cycle in premenopausal women (early versus late follicular phase).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Exercise Treadmill Test (ETT)</intervention_name>
      <description>Routinely ordered exercise treadmill test results will be reviewed in premenopausal women. ETT results and change in hs cTnI levels will be compared between the early and late follicular phases of menstrual cycle.</description>
      <arm_group_label>Exercise test results will be grouped based on the menstrual cycle.</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients in the premenopausal period between the ages of 18-60, who apply to the cardiology&#xD;
          outpatient clinics of Göztepe City Hospital with typical/atypical chest pain, and an&#xD;
          exercise treadmill test results positive according to the routine positivity criteria of&#xD;
          the exercise test will be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with suspected ischemia in the exercise test&#xD;
  &#xD;
            2. Age is ≥18&#xD;
  &#xD;
            3. Female patients in the pre-menopausal period&#xD;
  &#xD;
            4. Patients who can understand and sign the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with history of coronary artery disease or myocardial infarction&#xD;
  &#xD;
            2. Secondary Hypertension, Uncontrolled hypertension&#xD;
  &#xD;
            3. Peripheral artery disease&#xD;
  &#xD;
            4. Patients with severe heart valve disease&#xD;
  &#xD;
            5. Cardiac arrhythmia&#xD;
  &#xD;
            6. Heart failure&#xD;
  &#xD;
            7. Cancer patients&#xD;
  &#xD;
            8. Severe kidney (stage ≥ 3 kidney failure) chronic liver disease&#xD;
  &#xD;
            9. Those who do not have the level of consciousness or mental capacity to understand and&#xD;
               accept to participate in the study&#xD;
  &#xD;
           10. Pregnancy&#xD;
  &#xD;
           11. Those who use external hormonal therapy or drugs that will change the hormone level&#xD;
               i.e. oral contraceptives&#xD;
  &#xD;
           12. Acute pericarditis, myocarditis or myopericarditis&#xD;
  &#xD;
           13. Sepsis, systemic infections&#xD;
  &#xD;
           14. Women with signs and symptoms of perimenopause or menopause.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female patients in the pre-menopausal period</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Sukru Sadık Öner, MD PhD</last_name>
      <role>Study Director</role>
      <affiliation>Istanbul Medeniyet University City Hospital Goztepe</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mehmet Agirbasli, MD</last_name>
      <phone>90(532)7468840</phone>
      <email>agirbasli@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mehmet Agirbasli</last_name>
      <email>agirbasli@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istanbul Medeniyet University Hospital, Goztepe</name>
        <address>
          <city>Istanbul</city>
          <zip>34722</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mehmet Agirbasli</last_name>
        <phone>90(532)7468840</phone>
        <email>agirbasli@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
      <investigator_full_name>Mehmet Agirbasli MD</investigator_full_name>
      <investigator_title>Medical Doctor, Professor of Cardiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ischemia</mesh_term>
      <mesh_term>Menstruation Disturbances</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The results will be published as journal article</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05985980
  org study id: 2023/0129
  nct id: NCT05985980
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  False positive results are commonly observed in women after exercise treadmill test (ETT).
        The effects of menstrual periodic changes on the results of exercise treadmill test in
        premenopausal women have not been clearly defined. Primary purpose of the study is to
        investigate the biological causes of false positive test results in the treadmill exercise
        test in premenopausal women. Estrogen is known to have direct vasodilatory effects on
        coronary arteries. Early and late follicular phases of the menstrual cycle are characterized
        by low and high estrogen levels, respectively. The Early Follicular Phase starts on the first
        day of the menstrual cycle and ends when oestradiol begins to increase. It is characterised
        by increasing LH and FSH and constant low levels of oestradiol. The late follicular phase
        starts with the increase in oestradiol and ends at its preovulatory peak. The hypothesis of
        the study is that ETT results will change at the early and late follicular phases in
        premenstrual women. Premenopausal women between the ages of 18-40, who apply to the
        cardiology outpatient clinics of Göztepe City Hospital with typical/atypical chest pain, and
        an indication for ETT will be included in the study. ETT will be performed in the early and
        late follicular phases of the menstrual cycle, separately.
  Estrogen is known to have direct vasodilatory effects on coronary arteries. Early and late
        follicular phases of the menstrual cycle in premenopausal women are characterized by low and
        high estrogen levels, respectively. The Early Follicular Phase starts on the first day of the
        menstrual cycle and ends when oestradiol begins to increase. It is characterised by
        increasing LH and FSH and constant low levels of oestradiol. The late follicular phase starts
        with the increase in oestradiol and ends at its preovulatory peak. Premenopausal women
        (between the ages of 18-40), who apply to the cardiology outpatient clinics of Göztepe City
        Hospital with typical/atypical chest pain, and an indication for exercise treadmill test
        (ETT) will be included in the study. ETT will be performed in the early and late follicular
        phases of the menstrual cycle, separately.
  
        Forty (40) patients who meet these conditions will be included in the study.
  
        The menstrual cycle of the patient will be questioned in the screening interview.
        Premenopausal female patients between the ages of 18-40 who still have a regular menstrual
        cycles will be included in the study. Hormone levels including Estradiol III, follicle
        stimulating hormone (FSH), luteinizing hormone (LH), progesterone (Elecsys) will be measured
        to confirm the menstrual cycle before each ETT. ETT will be performed in the early and late
        follicular phases of the menstrual cycle, separately. Cardiac high sensitive troponin I (hs
        cTnI) (Roche) will be measured before and after ETT.
  
        Primary end point will the ST/HR (heart rate) index (μV/bpm) in ETT. The ST/HR index (μV/bpm)
        is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill & CASE
        6.73 Stress Test System.
  
        The secondary endpoints will be the change in hs cTnI between the before and after ETT,
        maximal exercise capacity (METs score), ST/HR slope (μV/bpm), maximal horizontal or down
        slope ST segment depression (mm) with exercise. Secondary end points other than cTnI are
        automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill & CASE
        6.73 Stress Test System.
  
        The null hypothesis is that there is no difference between in the ST/HR index (μV/bpm)
        between the menstrual phases. The power is calculated to prove the alternative hypothesis in
        which there is a 50 % difference between the ETT ST/HR index (μV/bpm). In a paired study
        sample, with type I error of 5 % and type II error of 20 %, the sample size is calculated as
        34 patients.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: ST/HR index (μV/bpm) in ETT.
  time frame: March-September 2023
  description: The ST/HR index (μV/bpm) is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill & CASE 6.73 Stress Test System.
  measure: change in the concentrations of high sensitive cardiac troponin I (ng/L) change before and after exercise
  time frame: May-September 2023
  description: hs cTnI will be measured by Roche kit.
  measure: maximal exercise capacity (METs score)
  time frame: May-September 2023
  description: automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill & CASE 6.73 Stress Test System.
  measure: ST/HR slope (μV/bpm)
  time frame: May-September 2023
  description: automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill & CASE 6.73 Stress Test System.
  measure: maximal horizontal or down slope ST segment depression (mm) with exercise
  time frame: May-September 2023
  description: automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill & CASE 6.73 Stress Test System.
  arm group label: Exercise test results will be grouped based on the menstrual cycle.
  description: Positive exercise treadmill tests will be repeated at a different phase of menstrual cycle in premenopausal women (early versus late follicular phase).
  intervention type: Diagnostic Test
  intervention name: Exercise Treadmill Test (ETT)
  description: Routinely ordered exercise treadmill test results will be reviewed in premenopausal women. ETT results and change in hs cTnI levels will be compared between the early and late follicular phases of menstrual cycle.
  arm group label: Exercise test results will be grouped based on the menstrual cycle.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female patients in the pre-menopausal period
  minimum age: 18 Years
  maximum age: 60 Years
  last name: Sukru Sadık Öner, MD PhD
  role: Study Director
  affiliation: Istanbul Medeniyet University City Hospital Goztepe
  last name: Mehmet Agirbasli, MD
  phone: 90(532)7468840
  email: agirbasli@gmail.com
  last name: Mehmet Agirbasli
  email: agirbasli@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medeniyet University
  investigator full name: Mehmet Agirbasli MD
  investigator title: Medical Doctor, Professor of Cardiology
  mesh term: Ischemia
  mesh term: Menstruation Disturbances
  sharing ipd: No
  ipd description: The results will be published as journal article