<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/NCT04487509</url>
  </required_header>
  <id_info>
    <org_study_id>INSYCO ST+</org_study_id>
    <nct_id>NCT04487509</nct_id>
  </id_info>
  <brief_title>Incidence Study on Acute Coronary Disease With ST Segment Elevation</brief_title>
  <acronym>InSyCoST+</acronym>
  <official_title>Incidence Study on Acute Coronary Disease With ST Segment Elevation (CAD ST +) in the Emergency Room (InSyCo ST + Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Universitaire Sahloul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Universitaire Sahloul</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>
      Cardiovascular disease, and in particular ischemic heart disease, is the main cause of&#xD;
      morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most&#xD;
      serious clinical entity through its short-term life threatening involvement.&#xD;
&#xD;
      The many advances in the management of IDM during the acute phase, namely the increasingly&#xD;
      frequent and effective use of reperfusion means (angioplasty and thrombolysis) as well as&#xD;
      pharmacological progress, in particular, the management of anti-thrombotic treatment has&#xD;
      enabled a significant reduction in intra-hospital mortality, in the medium and long term (2).&#xD;
      In fact, the mortality rate dropped from 25-30% before the creation of the cardiac intensive&#xD;
      care units (ICUS) around the 1960s, to around 16% in the 1980s and reaching 4 to 6% today. In&#xD;
      the latest data from the French FAST MI 2015 register (French Registry of Acute ST-Elevation&#xD;
      or Non-ST-elevation Myocardial Infarction) mortality was 2.8% in hospital (3) and 5.3% at 6&#xD;
      months (4). Nevertheless, mortality rates diverge from one register to another and are&#xD;
      generally higher compared to randomized controlled clinical trials.&#xD;
&#xD;
      In our country, due to the aging of the Tunisian population (currently the oldest population&#xD;
      in Africa), as well as the rise in the prevalence of cardiovascular risk factors (5), the&#xD;
      incidence of IDM is clearly increasing. However, our local specificities concerning the&#xD;
      management of this pathology and the intra-hospital mortality which results from it, remain&#xD;
      little described despite the importance of these data in the development of personalized&#xD;
      algorithms and the improvement of the quality of this support.&#xD;
&#xD;
      the management of CAD ST + in the public sector poses more and more efficiency problems and&#xD;
      moves away from international recommendations in our country, an assessment of our national&#xD;
      situation is necessary.&#xD;
&#xD;
      The objectives of the study are, primary, the incidence of new cases that consult the&#xD;
      emergency room for CAD ST + and the treatment delivered to the emergency room, in particular&#xD;
      the nature of the treatment for obstruction (primary angioplasty or thrombolysis). Secondary,&#xD;
      the evaluation of hospital complications and the future of patients on D30 and after one year&#xD;
      from the inclusion's day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease, and in particular ischemic heart disease, is the main cause of&#xD;
      morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most&#xD;
      serious clinical entity through its short-term life threatening involvement.&#xD;
&#xD;
      The many advances in the management of IDM during the acute phase, namely the increasingly&#xD;
      frequent and effective use of reperfusion means (angioplasty and thrombolysis) as well as&#xD;
      pharmacological progress, in particular, the management of anti-thrombotic treatment has&#xD;
      enabled a significant reduction in intra-hospital mortality, in the medium and long term (2).&#xD;
      In fact, the mortality rate dropped from 25-30% before the creation of the cardiac intensive&#xD;
      care units (ICUS) around the 1960s, to around 16% in the 1980s and reaching 4 to 6% today. In&#xD;
      the latest data from the French FAST MI 2015 register (French Registry of Acute ST-Elevation&#xD;
      or Non-ST-elevation Myocardial Infarction) mortality was 2.8% in hospital (3) and 5.3% at 6&#xD;
      months (4). Nevertheless, mortality rates diverge from one register to another and are&#xD;
      generally higher compared to randomized controlled clinical trials.&#xD;
&#xD;
      In our country, due to the aging of the Tunisian population (currently the oldest population&#xD;
      in Africa), as well as the rise in the prevalence of cardiovascular risk factors (5), the&#xD;
      incidence of IDM is clearly increasing. However, our local specificities concerning the&#xD;
      management of this pathology and the intra-hospital mortality which results from it, remain&#xD;
      little described despite the importance of these data in the development of personalized&#xD;
      algorithms and the improvement of the quality of this support.&#xD;
&#xD;
      the management of CAD ST + in the public sector poses more and more efficiency problems and&#xD;
      moves away from international recommendations in our country, an assessment of our national&#xD;
      situation is necessary.&#xD;
&#xD;
      The objectives of the study are, primary, the incidence of new cases that consult the&#xD;
      emergency room for CAD ST + and the treatment delivered to the emergency room, in particular&#xD;
      the nature of the treatment for obstruction (primary angioplasty or thrombolysis). Secondary,&#xD;
      the evaluation of hospital complications and the future of patients on D30 and after one year&#xD;
      from the inclusion's day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2018</start_date>
  <completion_date type="Actual">January 17, 2019</completion_date>
  <primary_completion_date type="Actual">December 17, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MORTALITY</measure>
    <time_frame>one month</time_frame>
    <description>Mortality will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CORONARY ANGIOPLASTY</measure>
    <time_frame>one month</time_frame>
    <description>Angioplasty will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COMPLICATIONS</measure>
    <time_frame>one month</time_frame>
    <description>Complications will be reported.</description>
  </secondary_outcome>
  <enrollment type="Actual">450</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Emergencies</condition>
  <condition>Complication</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>THROMBOLYSE</intervention_name>
    <description>the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis)</description>
    <other_name>OBSTRUCTION</other_name>
    <other_name>CORONARY ANGIOPLASTY</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Twenty four emergency departments are affected in this study for the recruitment of&#xD;
        patients. Two months from October 17th to December 17th for the inclusion of patients&#xD;
        including public holidays 24 hours 7 days a week plus a month of follow up.&#xD;
&#xD;
        Data collection Parameters of history (history) Schedules for clinical examinations&#xD;
        (triage, ECG) Treatments received in the emergency room Thrombolysis, specifying the&#xD;
        schedule and the molecule used Angioplasty, specifying the time and place Complication in&#xD;
        the emergency room (death, shock, abortion, rhythm disorder) Transfer and hospital&#xD;
        complications Becoming and coming from patients by a phone call Specify previous&#xD;
        complications (death, shock, abortion, rhythm disorder) Duration of hospital stay&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years&#xD;
&#xD;
          -  Acute ST + coronary syndrome, with an ST segment elevation on the ECG at point J in&#xD;
             two contiguous leads with the following thresholds: ≥0.1 mv in all leads except V2- V3&#xD;
             where the thresholds will be: ≥ 0.2 mV in men ≥ 40 years old; ≥ 0.25 mV in men.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ST plus equivalents (IVA syndrome, left branch block, etc.),&#xD;
&#xD;
          -  CAD without ST segment elevation&#xD;
&#xD;
          -  Patients arriving in cardiac arrest and not recovered after resuscitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boukef Riadh, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>HU Sahloul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HU Sahloul, sousse, Tunisia</name>
      <address>
        <city>Sousse</city>
        <state>Itinéraire Ceinture Cité Sahloul</state>
        <zip>4054</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <reference>
    <citation>Addad F, Mahdhaoui A, Gouider J, Boughzela E, Kamoun S, Boujnah MR, Haouala H, Gamra H, Maatouk F, Ben Khalfallah A, Kachboura S, Baccar H, Ben Halima N, Guesmi A, Sayahi K, Sdiri W, Neji A, Bouakez A, Milouchi S, Battikh K, Jullieres Y, Danchin N, Monsuez JJ, Mulak G, Hagege A, Bataille V, Chettaoui R, Mourali MS; FAST-MI Tunisia investigators. Management of patients with acute ST-elevation myocardial infarction: Results of the FAST-MI Tunisia Registry. PLoS One. 2019 Feb 22;14(2):e0207979. doi: 10.1371/journal.pone.0207979. eCollection 2019.</citation>
    <PMID>30794566</PMID>
  </reference>
  <reference>
    <citation>Trebouet E, Boiffard E, Debierre V, Fradin P. [Analysis of cardiovascular complications occurring during inter-hospital transfers of patients with non-ST elevation myocardial infarction]. Ann Cardiol Angeiol (Paris). 2019 Feb;68(1):13-16. doi: 10.1016/j.ancard.2018.08.019. Epub 2018 Oct 2. French.</citation>
    <PMID>30290916</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Universitaire Sahloul</investigator_affiliation>
    <investigator_full_name>Riadh Boukef</investigator_full_name>
    <investigator_title>PROFESSOR</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04487509
org study id: INSYCO ST+
nct id: NCT04487509
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease, and in particular ischemic heart disease, is the main cause of
      morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most
      serious clinical entity through its short-term life threatening involvement.

      The many advances in the management of IDM during the acute phase, namely the increasingly
      frequent and effective use of reperfusion means (angioplasty and thrombolysis) as well as
      pharmacological progress, in particular, the management of anti-thrombotic treatment has
      enabled a significant reduction in intra-hospital mortality, in the medium and long term (2).
      In fact, the mortality rate dropped from 25-30% before the creation of the cardiac intensive
      care units (ICUS) around the 1960s, to around 16% in the 1980s and reaching 4 to 6% today. In
      the latest data from the French FAST MI 2015 register (French Registry of Acute ST-Elevation
      or Non-ST-elevation Myocardial Infarction) mortality was 2.8% in hospital (3) and 5.3% at 6
      months (4). Nevertheless, mortality rates diverge from one register to another and are
      generally higher compared to randomized controlled clinical trials.

      In our country, due to the aging of the Tunisian population (currently the oldest population
      in Africa), as well as the rise in the prevalence of cardiovascular risk factors (5), the
      incidence of IDM is clearly increasing. However, our local specificities concerning the
      management of this pathology and the intra-hospital mortality which results from it, remain
      little described despite the importance of these data in the development of personalized
      algorithms and the improvement of the quality of this support.

      the management of CAD ST + in the public sector poses more and more efficiency problems and
      moves away from international recommendations in our country, an assessment of our national
      situation is necessary.

      The objectives of the study are, primary, the incidence of new cases that consult the
      emergency room for CAD ST + and the treatment delivered to the emergency room, in particular
      the nature of the treatment for obstruction (primary angioplasty or thrombolysis). Secondary,
      the evaluation of hospital complications and the future of patients on D30 and after one year
      from the inclusion's day.
Cardiovascular disease, and in particular ischemic heart disease, is the main cause of
      morbidity and mortality worldwide today (1). Myocardial infarction (MI) presents the most
      serious clinical entity through its short-term life threatening involvement.

      The many advances in the management of IDM during the acute phase, namely the increasingly
      frequent and effective use of reperfusion means (angioplasty and thrombolysis) as well as
      pharmacological progress, in particular, the management of anti-thrombotic treatment has
      enabled a significant reduction in intra-hospital mortality, in the medium and long term (2).
      In fact, the mortality rate dropped from 25-30% before the creation of the cardiac intensive
      care units (ICUS) around the 1960s, to around 16% in the 1980s and reaching 4 to 6% today. In
      the latest data from the French FAST MI 2015 register (French Registry of Acute ST-Elevation
      or Non-ST-elevation Myocardial Infarction) mortality was 2.8% in hospital (3) and 5.3% at 6
      months (4). Nevertheless, mortality rates diverge from one register to another and are
      generally higher compared to randomized controlled clinical trials.

      In our country, due to the aging of the Tunisian population (currently the oldest population
      in Africa), as well as the rise in the prevalence of cardiovascular risk factors (5), the
      incidence of IDM is clearly increasing. However, our local specificities concerning the
      management of this pathology and the intra-hospital mortality which results from it, remain
      little described despite the importance of these data in the development of personalized
      algorithms and the improvement of the quality of this support.

      the management of CAD ST + in the public sector poses more and more efficiency problems and
      moves away from international recommendations in our country, an assessment of our national
      situation is necessary.

      The objectives of the study are, primary, the incidence of new cases that consult the
      emergency room for CAD ST + and the treatment delivered to the emergency room, in particular
      the nature of the treatment for obstruction (primary angioplasty or thrombolysis). Secondary,
      the evaluation of hospital complications and the future of patients on D30 and after one year
      from the inclusion's day.
observational model: Cohort
time perspective: Prospective
measure: MORTALITY
time frame: one month
description: Mortality will be reported.
measure: CORONARY ANGIOPLASTY
time frame: one month
description: Angioplasty will be reported.
measure: COMPLICATIONS
time frame: one month
description: Complications will be reported.
intervention type: Other
intervention name: THROMBOLYSE
description: the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis)
other name: OBSTRUCTION
other name: CORONARY ANGIOPLASTY
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boukef Riadh, professor
role: Principal Investigator
affiliation: HU Sahloul
facility: 
country: Tunisia
citation: Addad F, Mahdhaoui A, Gouider J, Boughzela E, Kamoun S, Boujnah MR, Haouala H, Gamra H, Maatouk F, Ben Khalfallah A, Kachboura S, Baccar H, Ben Halima N, Guesmi A, Sayahi K, Sdiri W, Neji A, Bouakez A, Milouchi S, Battikh K, Jullieres Y, Danchin N, Monsuez JJ, Mulak G, Hagege A, Bataille V, Chettaoui R, Mourali MS; FAST-MI Tunisia investigators. Management of patients with acute ST-elevation myocardial infarction: Results of the FAST-MI Tunisia Registry. PLoS One. 2019 Feb 22;14(2):e0207979. doi: 10.1371/journal.pone.0207979. eCollection 2019.
PMID: 30794566
citation: Trebouet E, Boiffard E, Debierre V, Fradin P. [Analysis of cardiovascular complications occurring during inter-hospital transfers of patients with non-ST elevation myocardial infarction]. Ann Cardiol Angeiol (Paris). 2019 Feb;68(1):13-16. doi: 10.1016/j.ancard.2018.08.019. Epub 2018 Oct 2. French.
PMID: 30290916
responsible party type: Principal Investigator
investigator affiliation: Hôpital Universitaire Sahloul
investigator full name: Riadh Boukef
investigator title: PROFESSOR
mesh term: Myocardial Infarction
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Infarction
mesh term: Emergencies
sharing ipd: No