<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/NCT03234023</url>
  </required_header>
  <id_info>
    <org_study_id>2017/101</org_study_id>
    <secondary_id>SPRING</secondary_id>
    <nct_id>NCT03234023</nct_id>
  </id_info>
  <brief_title>Secondary PRevention in Cardiovascular Disease by a Nursing Guide Program (SPRING)</brief_title>
  <acronym>SPRING</acronym>
  <official_title>Secondary PRevention in Cardiovascular Diseaseby a Nursing Guide Program. SPRING Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital A Coruña</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital A Coruña</source>
  <oversight_info>
    <has_dmc>Yes</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>
      DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric.&#xD;
&#xD;
      CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO&#xD;
      STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored not supervised. MAIN OBJECTIVE:&#xD;
      To determine the incidence of major adverse cardiac events, MACE (total mortality, new ACS,&#xD;
      coronary revascularization, all-cause hospitalization) during the one-year period after&#xD;
      hospitalization for ACS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">February 5, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 5, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>major adverse cardiac events</measure>
    <time_frame>2 years</time_frame>
    <description>(total mortality, new ACS, coronary revascularization, hospitalization for any cause)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">484</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Nutrition</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>INTERVENTION GROUP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants of this group will follow recommendations of food, physical exercise, control of consumption of drugs and consumption of alcohol and tobacco.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL GROUP</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants of this group are submitted to the standard intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>INTERVENTION GROUP</intervention_name>
    <description>Offer recommendations of healthy living habits and control of pharmacy administration</description>
    <arm_group_label>INTERVENTION GROUP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who have suffered an ACS in the health area of A Coruña from the&#xD;
             beginning of the study inclusion period until reaching the fixed sample size.&#xD;
&#xD;
          -  Ages between 18 and 75 years.&#xD;
&#xD;
          -  Patients with ability to read and understand the participation sheet in the study.&#xD;
&#xD;
          -  Patients signing informed consent to participate in the study.&#xD;
&#xD;
          -  Patients living in the health care area of HUAC.&#xD;
&#xD;
          -  Patients who possess and know how to operate with a smart mobile phone (Smartphone&#xD;
             type).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are dependent for the Basic Activities of Daily Living (BADL) or who&#xD;
             suffer from severe cognitive impairment (which makes reliable anamnesis impossible).&#xD;
&#xD;
          -  Patients with a Left Ventricular Ejection Fraction (LVEF) less than or equal to 30%.&#xD;
&#xD;
          -  Patients with a NYHA III / IV score and / or the Canadian Cardiovascular Association&#xD;
             (CCS) scale of IV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmen Neri Fernández Pombo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital A Coruña</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Ferrol</name>
      <address>
        <city>Ferrol</city>
        <state>A Coruña</state>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of A Coruña</name>
      <address>
        <city>A Coruña</city>
        <state>Galicia</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>October 3, 2022</last_update_submitted>
  <last_update_submitted_qc>October 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital A Coruña</investigator_affiliation>
    <investigator_full_name>CARMEN NERI FERNANDEZ POMBO</investigator_full_name>
    <investigator_title>Research Nurse.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data of the participants can not be used by other researchers</ipd_description>
  </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/NCT03234023
org study id: 2017/101
secondary id: SPRING
nct id: NCT03234023
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric.

      CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO
      STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored not supervised. MAIN OBJECTIVE:
      To determine the incidence of major adverse cardiac events, MACE (total mortality, new ACS,
      coronary revascularization, all-cause hospitalization) during the one-year period after
      hospitalization for ACS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: major adverse cardiac events
time frame: 2 years
description: (total mortality, new ACS, coronary revascularization, hospitalization for any cause)
arm group label: INTERVENTION GROUP
arm group type: Active Comparator
description: The participants of this group will follow recommendations of food, physical exercise, control of consumption of drugs and consumption of alcohol and tobacco.
arm group label: CONTROL GROUP
arm group type: No Intervention
description: The participants of this group are submitted to the standard intervention.
intervention type: Behavioral
intervention name: INTERVENTION GROUP
description: Offer recommendations of healthy living habits and control of pharmacy administration
arm group label: INTERVENTION GROUP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Carmen Neri Fernández Pombo, PhD
role: Principal Investigator
affiliation: University Hospital A Coruña
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University Hospital A Coruña
investigator full name: CARMEN NERI FERNANDEZ POMBO
investigator title: Research Nurse.
mesh term: Acute Coronary Syndrome
sharing ipd: No
ipd description: The data of the participants can not be used by other researchers