NCT03070496: HIBISCUS-STEMI

Multicenter Cohort of STEMI Patients

Completed NA Last updated 10 September 2025

What this trial tests

NA trial testing Blood sampling in STEMI - ST Elevation Myocardial Infarction in 281 participants. Completed in 5 June 2023.

Timeline

7 March 2017

Primary endpoint
5 June 2023

5 June 2023

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	281
Start date	7 March 2017
Primary completion	5 June 2023
Estimated completion	5 June 2023
Sites	3 locations across France

Drugs / interventions tested

• Blood sampling — full drug profile →
• ECG
• MRI — full drug profile →
• Quality of life questionnaire

Conditions studied

• STEMI - ST Elevation Myocardial Infarction — all drugs for STEMI - ST Elevation Myocardial Infarction →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with STEMI - ST Elevation Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Serum Soluble Tumor Necrosis Factor Receptors 1 and 2 Are Early Prognosis Markers After ST-Segment Elevation Myocardial Infarction.
   Paccalet A, Crola Da Silva C, Mechtouff L, Amaz C, et al · · 2021 · cited 21× · PMID 34539391 · DOI 10.3389/fphar.2021.656928
2. Myocardial Ischemia-Reperfusion and Diabetes: Lessons Learned From Bedside to Bench.
   Dia M, Paccalet A, Pillot B, Leon C, et al · · 2021 · cited 9× · PMID 33842565 · DOI 10.3389/fcvm.2021.660698
3. Human peripheral blood mononuclear cells display a temporal evolving inflammatory profile after myocardial infarction and modify myocardial fibroblasts phenotype.
   Miquelestorena-Standley E, da Silva AVV, Monnier M, Chadet S, et al · · 2023 · cited 7× · PMID 37798364 · DOI 10.1038/s41598-023-44036-3
4. Kinetics and Prognosis Value of CCL5/RANTES at the Acute Phase of ST-Segment-Elevation Myocardial Infarction.
   Brun C, Moulin F, Leboube S, Hayek A, et al · · 2024 · cited 1× · PMID 39319665 · DOI 10.1161/jaha.123.033110
5. The Uremic Toxin p-Cresyl Sulfate Is a New Predictor of Major Adverse Cardiovascular Events in Patients with ST-Elevation Myocardial Infarction.
   Raillon LA, Bochaton T, Glorieux G, Guebre-Egziabher F, et al · · 2025 · PMID 41591151 · DOI 10.3390/toxins18010004
6. Role of heparin-induced HGF release in the acute phase of STEMI.
   Leboube S, Paccalet A, Brun C, Moulin F, et al · · 2025 · PMID 41282338 · DOI 10.3389/fcvm.2025.1668882
7. Comparison of synthetic LGE with optimal inversion time vs. conventional LGE via representation learning: Quantification of Bias in Population Analysis.
   Deleat-Besson R, Viallon M, Petrusca L, Croisille P, et al · · 2025 · PMID 40675093 · DOI 10.1016/j.compbiomed.2025.110643