Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicenter Cohort of STEMI Patients (HIBISCUS-STEMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070496
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date February 10, 2020
Actual Study Start Date  ICMJE March 7, 2017
Estimated Primary Completion Date March 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
Heart failure stage [ Time Frame: Up to 3 years after myocardial infarction ]
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Infarct size [ Time Frame: 1 month after myocardial infarction ]
    Infarct size will be measured on MRI
  • Cardiac enzymes rate [ Time Frame: H0 (admission in coronary angiography room) ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: H4 (4 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: H24 (24 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: H48 (48 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 1 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 3 months after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 6 months after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 12 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • EQ-5D score [ Time Frame: 12 month after myocardial infarction ]
    Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • Infarct size [ Time Frame: 1 month after myocardial infarction ]
    Infarct size will be measured on MRI
  • Infarct size [ Time Frame: 12 months after myocardial infarction ]
    Infarct size will be measured on MRI
  • Infarct size [ Time Frame: 36 months after myocardial infarction ]
    Infarct size will be measured on MRI
  • Cardiac enzymes rate [ Time Frame: H0 (admission in coronary angiography room) ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: H4 (4 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: H24 (24 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: H48 (48 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 1 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 3 months after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 6 months after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 12 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 24 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • Cardiac enzymes rate [ Time Frame: 36 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples
  • EQ-5D score [ Time Frame: 12 month after myocardial infarction ]
    Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire
  • EQ-5D score [ Time Frame: 24 month after myocardial infarction ]
    Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire
  • EQ-5D score [ Time Frame: 36 month after myocardial infarction ]
    Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Cohort of STEMI Patients
Official Title  ICMJE CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction
Brief Summary

Ischemic heart disease is the leading cause of mortality with 7.2 million of death in industrialized countries (WHO data). Myocardial infarction corresponding to acute occlusion of a coronary artery is the most brutal form and the more severe ischemic myocardial disease. Every year in France, about 60,000 Myocardial infarctions hospitalized, 30,000 are diagnosed remotely and 30,000 are revealed by an inaugural sudden death. Although mortality from myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult to assess precisely. The management of the patient depends on these factors, and justifies an active search on these topics, including the mechanisms of the deleterious ventricular remodeling, myocardial inflammation, reperfusion injury which determines in particular the evolution to heart failure. Cohorts of patients with myocardial infarction are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.

The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after acute myocardial infarction.

Secondary objectives of the HIBISCUS-STEMI cohort to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:

  • Descriptive epidemiology of myocardial infarction and myocardial reperfusion
  • Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs
  • Assessment of the long-term effect of the treatment on the occurrence of heart failure and sudden death
  • Quality of life and personal consequences, family, professional and social myocardial infarction
  • Research of new diagnostic and prognostic biomarkers
  • Research projects (e.g. risk of developing kidney failure or stroke in patients with myocardial infarction compared to the general population).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE STEMI - ST Elevation Myocardial Infarction
Intervention  ICMJE
  • Biological: Blood sampling
    Blood sampling will be performed at 6 months after myocardial infarction to analyse diagnostic and prognostic biomarkers
  • Procedure: ECG
    ECG will be performed at 6 months after myocardial infarction
  • Device: MRI
    MRI will be performed at 1month after myocardial infarction to analyse ventricular remodeling and reperfusion.
  • Other: Quality of life questionnaire
    Patients will pass a quality of life questionnaire at 12 months after myocardial infarction
Study Arms  ICMJE Experimental: STEMI cohort

Patients recruited in the cohort will have 4 additional interventions compared to the usual follow-up :

  • an additional blood sampling at 6 months
  • an additional electrocardiogram (ECG) at 6 months
  • Magnetic Resonance Imaging (MRI)
  • Quality of life questionnaire
Interventions:
  • Biological: Blood sampling
  • Procedure: ECG
  • Device: MRI
  • Other: Quality of life questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
350
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
500
Estimated Study Completion Date  ICMJE March 7, 2022
Estimated Primary Completion Date March 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years old
  • Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
  • Primary Percutaneous coronary intervention (PCI)

Exclusion Criteria:

  • Diagnosis of STEMI not confirmed by angiography
  • Refusal to participate in the study or to sign the consent
  • Impossibility to give information to the subject about the study
  • Lack of medical social coverage
  • Obvious contraindication to magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, renal insufficiency, known allergy to a contrast agent)
  • Deprivation of civil rights
  • participating to another interventional study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michel OVIZE, MD, PhD +33 472 357 170 ghe.ciclyon@chu-lyon.fr
Contact: Yvonne VARILLON, CRA +33 472 35 69 64 yvonne.varillona@chu-lyon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03070496
Other Study ID Numbers  ICMJE 69HCL16_0570
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel OVIZE, MD, PhD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP