Multicenter Cohort of STEMI Patients (HIBISCUS-STEMI)

CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction

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).

Study Overview

• Status: Unknown
• Conditions: STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Biological: Blood sampling; Procedure: ECG; Device: MRI; Other: Quality of life questionnaire

• Study Type: Interventional
• Enrollment (Anticipated): 281
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michel OVIZE, MD, PhD; Phone Number: +33 472 357 170; Email: ghe.ciclyon@chu-lyon.fr
• Study Contact Backup: Name: Yvonne VARILLON, CRA; Phone Number: +33 472 35 69 64; Email: yvonne.varillona@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69677
    • Recruiting
    • Hôpital Cardiovasculaire Louis Pradel
    • Contact: Michel OVIZE, MD, PhD; Phone Number: +33 472 357 170; Email: ghe.ciclyon@chu-lyon.fr
    • Contact: Lakhdar BENYAHYA, CRA; Phone Number: +33 472 356 972; Email: lakhdar.benyahya@chu-lyon.fr
    • Principal Investigator: Michel OVIZE, MD, PhD
  • Strasbourg, France, 67091
    • Recruiting
    • CHU Strasbourg
    • Contact: Olivier MOREL, MD, PhD
    • Principal Investigator: Olivier MOREL, MD, PhD
  • Tours, France
    • Recruiting
    • CHU de Tours
    • Contact: Denis ANGOULVANT, MD, PhD
    • Principal Investigator: Denis ANGOULVANT, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure stage	Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification	Up to 3 years after myocardial infarction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct size	Infarct size will be measured on MRI	1 month after myocardial infarction
Cardiac enzymes rate	Cardiac enzymes rate will be analysed in blood samples	H0 (admission in coronary angiography room)
Cardiac enzymes rate	Cardiac enzymes rate will be analysed in blood samples	H4 (4 hours after reperfusion)
Cardiac enzymes rate	Cardiac enzymes rate will be analysed in blood samples	H24 (24 hours after reperfusion)
Cardiac enzymes rate	Cardiac enzymes rate will be analysed in blood samples	H48 (48 hours after reperfusion)
Cardiac enzymes rate	Cardiac enzymes rate will be analysed in blood samples	1 month after myocardial infarction
Cardiac enzymes rate	Cardiac enzymes rate will be analysed in blood samples	3 months after myocardial infarction
Cardiac enzymes rate	Cardiac enzymes rate will be analysed in blood samples	6 months after myocardial infarction
Cardiac enzymes rate	Cardiac enzymes rate will be analysed in blood samples	12 month after myocardial infarction
EQ-5D score	Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire	12 month after myocardial infarction

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Michel OVIZE, MD, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Anticipated): December 7, 2022
• Study Completion (Anticipated): December 7, 2022

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: biomarkers; STEMI; Myocardial infarction; clinical outcomes; Imaging markers; bio-collection
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 69HCL16_0570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No