Multicenter Cohort of STEMI Patients (HIBISCUS-STEMI)
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| ClinicalTrials.gov Identifier: NCT03070496 |
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Recruitment Status :
Recruiting
First Posted : March 3, 2017
Last Update Posted : February 10, 2020
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Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | February 28, 2017 | ||||||||
| First Posted Date ICMJE | March 3, 2017 | ||||||||
| Last Update Posted Date | February 10, 2020 | ||||||||
| Actual Study Start Date ICMJE | March 7, 2017 | ||||||||
| Estimated Primary Completion Date | March 7, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Heart failure stage [ Time Frame: Up to 3 years after myocardial infarction ] Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Multicenter Cohort of STEMI Patients | ||||||||
| Official Title ICMJE | CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction | ||||||||
| 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:
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE | STEMI - ST Elevation Myocardial Infarction | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: STEMI cohort
Patients recruited in the cohort will have 4 additional interventions compared to the usual follow-up :
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
350 | ||||||||
| Original Estimated Enrollment ICMJE |
500 | ||||||||
| Estimated Study Completion Date ICMJE | March 7, 2022 | ||||||||
| Estimated Primary Completion Date | March 7, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03070496 | ||||||||
| Other Study ID Numbers ICMJE | 69HCL16_0570 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Hospices Civils de Lyon | ||||||||
| Study Sponsor ICMJE | Hospices Civils de Lyon | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Hospices Civils de Lyon | ||||||||
| Verification Date | February 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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