Multicenter Cohort of STEMI Patients

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— HIBISCUS-STEMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03070496
• Other study ID #: 69HCL16_0570
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: December 7, 2022

Study information

• Verified date: March 2021
• Source: Hospices Civils de Lyon
• Contact: Michel OVIZE, MD, PhD
• Phone: +33 472 357 170
• Email: ghe.ciclyon[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 281
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cardiovasculaire Louis Pradel	Bron
France	CHU Strasbourg	Strasbourg
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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