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Cohort of STEMI Patients 2 (HIBISCUS STEMI)

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Biocollection
Quality of life questionaries
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG. Management in primary ACT Prior oral informed consent followed by signed informed consent as soon as possible. Exclusion Criteria: Diagnosis of STEMI not confirmed on angiography Inability to give the subject informed information Lack of coverage by a social security scheme Obvious contraindication to injected magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, or a metallic body (ferromagnetic), severe renal insufficiency (GFR<30 ml/min), known allergy to the contrast medium ....) Pregnant woman or woman of childbearing age without effective contraception, breastfeeding woman. Deprivation of civil rights (curators, guardianship, safeguard of justice)

Sites / Locations

  • Hospices Civils de Lyon - Hôpital Louis PradelRecruiting
  • Hospices Civils de Lyon - Hôpital de la Croix RousseRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort group

Arm Description

patient with ST-segment elevation myocardial infarction.

Outcomes

Primary Outcome Measures

Research of potential new markers
Biomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation)

Secondary Outcome Measures

Calculation of infarct size on MRI
Measurement of reperfusion lesions on MRI (mass in grams)
Pharmacoepidemiology of myocardial infarction.
Description and evolution of patients' medical treatment between hospital discharge and 5 years follow-up.
Events between inclusion and 5 years follow-up
Time to a major adverse cardiovascular event

Full Information

First Posted
February 6, 2023
Last Updated
May 15, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05794022
Brief Title
Cohort of STEMI Patients 2
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
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
June 3, 2029 (Anticipated)
Study Completion Date
June 3, 2029 (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
ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort). The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort group
Arm Type
Other
Arm Description
patient with ST-segment elevation myocardial infarction.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
1 MRI at 1 month with gadolinium injection
Intervention Type
Biological
Intervention Name(s)
Biocollection
Intervention Description
Biocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples.
Intervention Type
Behavioral
Intervention Name(s)
Quality of life questionaries
Intervention Description
EQ-5D-5L and HAD questionaries at 1 month and 1 year.
Primary Outcome Measure Information:
Title
Research of potential new markers
Description
Biomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Calculation of infarct size on MRI
Description
Measurement of reperfusion lesions on MRI (mass in grams)
Time Frame
1 month
Title
Pharmacoepidemiology of myocardial infarction.
Description
Description and evolution of patients' medical treatment between hospital discharge and 5 years follow-up.
Time Frame
5 years
Title
Events between inclusion and 5 years follow-up
Description
Time to a major adverse cardiovascular event
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG. Management in primary ACT Prior oral informed consent followed by signed informed consent as soon as possible. Exclusion Criteria: Diagnosis of STEMI not confirmed on angiography Inability to give the subject informed information Lack of coverage by a social security scheme Obvious contraindication to injected magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, or a metallic body (ferromagnetic), severe renal insufficiency (GFR<30 ml/min), known allergy to the contrast medium ....) Pregnant woman or woman of childbearing age without effective contraception, breastfeeding woman. Deprivation of civil rights (curators, guardianship, safeguard of justice)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas BOCHATON, Dr
Phone
04 72 35 75 41
Ext
+33
Email
thomas.bochaton@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne VARILLON
Phone
04 72 35 69 64
Ext
+33
Email
yvonne.varillon@chu-lyon.fr
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Louis Pradel
City
Bron
State/Province
Rhone
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas BOCHATON, Dr
Phone
04 72 35 75 41
Ext
+33
Email
thomas.bochaton@chu-lyon.fr
Facility Name
Hospices Civils de Lyon - Hôpital de la Croix Rousse
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brahim HARBAOUI, Pr
Phone
04 72 35 58 25
Ext
+33
Email
brahim.harbaoui@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Cohort of STEMI Patients 2

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