NCT03070496

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

March 7, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

6.2 years

First QC Date

February 28, 2017

Last Update Submit

September 3, 2025

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

Myocardial infarctionbio-collectionImaging markersbiomarkersSTEMIclinical outcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Infarct size

    1 month after myocardial infarction

  • Cardiac enzymes rate

    H0 (admission in coronary angiography room)

  • Cardiac enzymes rate

    H4 (4 hours after reperfusion)

  • Cardiac enzymes rate

    H24 (24 hours after reperfusion)

  • Cardiac enzymes rate

    H48 (48 hours after reperfusion)

  • +5 more secondary outcomes

Study Arms (1)

STEMI cohort

EXPERIMENTAL

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 samplingProcedure: ECGDevice: MRIOther: Quality of life questionnaire

Interventions

Blood samplingBIOLOGICAL

Blood sampling will be performed at 6 months after myocardial infarction to analyse diagnostic and prognostic biomarkers

STEMI cohort
ECGPROCEDURE

ECG will be performed at 6 months after myocardial infarction

STEMI cohort
MRIDEVICE

MRI will be performed at 1month after myocardial infarction to analyse ventricular remodeling and reperfusion.

STEMI cohort
Quality of life questionnaireOTHER

Patients will pass a quality of life questionnaire at 12 months after myocardial infarction

STEMI cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Cardiovasculaire Louis Pradel

Bron, 69677, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

CHU de Tours

Tours, France

Location

Related Publications (1)

  • Paccalet A, Crola Da Silva C, Mechtouff L, Amaz C, Varillon Y, de Bourguignon C, Cartier R, Prieur C, Tomasevic D, Genot N, Leboube S, Derimay F, Rioufol G, Bonnefoy-Cudraz E, Mewton N, Ovize M, Bidaux G, Bochaton T. Serum Soluble Tumor Necrosis Factor Receptors 1 and 2 Are Early Prognosis Markers After ST-Segment Elevation Myocardial Infarction. Front Pharmacol. 2021 Sep 1;12:656928. doi: 10.3389/fphar.2021.656928. eCollection 2021.

    PMID: 34539391BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Michel OVIZE, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

March 7, 2017

Primary Completion

June 5, 2023

Study Completion

June 5, 2023

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)