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Multicenter Cohort of STEMI Patients (HIBISCUS-STEMI)

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ClinicalTrials.gov Identifier: NCT03070496
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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).

Condition or disease Intervention/treatment Phase
STEMI - ST Elevation Myocardial Infarction Biological: Blood sampling Procedure: ECG Device: MRI Other: Quality of life questionnaire Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : March 7, 2022
Estimated Study Completion Date : March 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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
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 1, 12 and 36 months after myocardial infarction to analyse ventricular remodeling and reperfusion.

Other: Quality of life questionnaire
Patients will pass a quality of life questionnaire at 12, 24 and 36 months after myocardial infarction




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Infarct size [ Time Frame: 1 month after myocardial infarction ]
    Infarct size will be measured on MRI

  2. Infarct size [ Time Frame: 12 months after myocardial infarction ]
    Infarct size will be measured on MRI

  3. Infarct size [ Time Frame: 36 months after myocardial infarction ]
    Infarct size will be measured on MRI

  4. Cardiac enzymes rate [ Time Frame: H0 (admission in coronary angiography room) ]
    Cardiac enzymes rate will be analysed in blood samples

  5. Cardiac enzymes rate [ Time Frame: H4 (4 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples

  6. Cardiac enzymes rate [ Time Frame: H24 (24 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples

  7. Cardiac enzymes rate [ Time Frame: H48 (48 hours after reperfusion) ]
    Cardiac enzymes rate will be analysed in blood samples

  8. Cardiac enzymes rate [ Time Frame: 1 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples

  9. Cardiac enzymes rate [ Time Frame: 3 months after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples

  10. Cardiac enzymes rate [ Time Frame: 6 months after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples

  11. Cardiac enzymes rate [ Time Frame: 12 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples

  12. Cardiac enzymes rate [ Time Frame: 24 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples

  13. Cardiac enzymes rate [ Time Frame: 36 month after myocardial infarction ]
    Cardiac enzymes rate will be analysed in blood samples

  14. EQ-5D score [ Time Frame: 12 month after myocardial infarction ]
    Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire

  15. EQ-5D score [ Time Frame: 24 month after myocardial infarction ]
    Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire

  16. EQ-5D score [ Time Frame: 36 month after myocardial infarction ]
    Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070496


Contacts
Contact: Michel OVIZE, MD, PhD +33 472 357 170 ghe.ciclyon@chu-lyon.fr
Contact: Lakhdar BENYAHYA, CRA +33 472 356 972 lakhdar.benyahya@chu-lyon.fr

Locations
France
Hôpital Cardiovasculaire Louis Pradel Recruiting
Bron, France, 69677
Contact: Michel OVIZE, MD, PhD    +33 472 357 170    ghe.ciclyon@chu-lyon.fr   
Contact: Lakhdar BENYAHYA, CRA    +33 472 356 972    lakhdar.benyahya@chu-lyon.fr   
Principal Investigator: Michel OVIZE, MD, PhD         
CHU Strasbourg Not yet recruiting
Strasbourg, France, 67091
Contact: Olivier MOREL, MD, PhD         
Principal Investigator: Olivier MOREL, MD, PhD         
CHU de Toulouse - Hôpital Rangueil Not yet recruiting
Toulouse, France, 31059
Contact: Meyer ELBAZ, MD, PhD         
Principal Investigator: Meyer ELBAZ, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Michel OVIZE, MD, PhD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03070496     History of Changes
Other Study ID Numbers: 69HCL16_0570
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Myocardial infarction
bio-collection
Imaging markers
biomarkers
STEMI
clinical outcomes

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases