Multicenter Cohort of STEMI Patients (HIBISCUS-STEMI)
Primary Purpose
STEMI - ST Elevation Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
ECG
MRI
Quality of life questionnaire
Sponsored by
About this trial
This is an interventional basic science trial for STEMI - ST Elevation Myocardial Infarction focused on measuring Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes
Eligibility 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
Sites / Locations
- Hôpital Cardiovasculaire Louis PradelRecruiting
- CHU StrasbourgRecruiting
- CHU de ToursRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STEMI cohort
Arm Description
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
Outcomes
Primary Outcome Measures
Heart failure stage
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
Secondary Outcome Measures
Infarct size
Infarct size will be measured on MRI
Cardiac enzymes rate
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate
Cardiac enzymes rate will be analysed in blood samples
EQ-5D score
Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire
Full Information
NCT ID
NCT03070496
First Posted
February 28, 2017
Last Updated
March 29, 2021
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03070496
Brief Title
Multicenter Cohort of STEMI Patients
Acronym
HIBISCUS-STEMI
Official Title
CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
December 7, 2022 (Anticipated)
Study Completion Date
December 7, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI - ST Elevation Myocardial Infarction
Keywords
Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
281 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STEMI cohort
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Blood sampling will be performed at 6 months after myocardial infarction to analyse diagnostic and prognostic biomarkers
Intervention Type
Procedure
Intervention Name(s)
ECG
Intervention Description
ECG will be performed at 6 months after myocardial infarction
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI will be performed at 1month after myocardial infarction to analyse ventricular remodeling and reperfusion.
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaire
Intervention Description
Patients will pass a quality of life questionnaire at 12 months after myocardial infarction
Primary Outcome Measure Information:
Title
Heart failure stage
Description
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
Time Frame
Up to 3 years after myocardial infarction
Secondary Outcome Measure Information:
Title
Infarct size
Description
Infarct size will be measured on MRI
Time Frame
1 month after myocardial infarction
Title
Cardiac enzymes rate
Description
Cardiac enzymes rate will be analysed in blood samples
Time Frame
H0 (admission in coronary angiography room)
Title
Cardiac enzymes rate
Description
Cardiac enzymes rate will be analysed in blood samples
Time Frame
H4 (4 hours after reperfusion)
Title
Cardiac enzymes rate
Description
Cardiac enzymes rate will be analysed in blood samples
Time Frame
H24 (24 hours after reperfusion)
Title
Cardiac enzymes rate
Description
Cardiac enzymes rate will be analysed in blood samples
Time Frame
H48 (48 hours after reperfusion)
Title
Cardiac enzymes rate
Description
Cardiac enzymes rate will be analysed in blood samples
Time Frame
1 month after myocardial infarction
Title
Cardiac enzymes rate
Description
Cardiac enzymes rate will be analysed in blood samples
Time Frame
3 months after myocardial infarction
Title
Cardiac enzymes rate
Description
Cardiac enzymes rate will be analysed in blood samples
Time Frame
6 months after myocardial infarction
Title
Cardiac enzymes rate
Description
Cardiac enzymes rate will be analysed in blood samples
Time Frame
12 month after myocardial infarction
Title
EQ-5D score
Description
Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire
Time Frame
12 month after myocardial infarction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel OVIZE, MD, PhD
Phone
+33 472 357 170
Email
ghe.ciclyon@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne VARILLON, CRA
Phone
+33 472 35 69 64
Email
yvonne.varillona@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel OVIZE, MD, PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cardiovasculaire Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel OVIZE, MD, PhD
Phone
+33 472 357 170
Email
ghe.ciclyon@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Lakhdar BENYAHYA, CRA
Phone
+33 472 356 972
Email
lakhdar.benyahya@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Michel OVIZE, MD, PhD
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MOREL, MD, PhD
First Name & Middle Initial & Last Name & Degree
Olivier MOREL, MD, PhD
Facility Name
CHU de Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis ANGOULVANT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Denis ANGOULVANT, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Multicenter Cohort of STEMI Patients
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