PROgnostic value of precision medicine in patients with Myocardial Infarction and non-obStructive coronary artEries: the PROMISE study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS4 sites in 1 country145 target enrollmentNovember 26, 2024

DrugsACETYLCHOLINE CHLORIDE BISOPROLOL WARFARIN ACETYLSALICYLIC ACID ATORVASTATIN LYSINE ASPIRIN CLOPIDOGREL GLYCERYL TRINITRATE DILTIAZEM RAMIPRIL

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment: 145
Locations: 4
Primary Endpoint: Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up in patients with MINOCA
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To test if a precision-medicine approach with a careful investigation of the MINOCA aetiology and consequent aetiology-based treatment may result in improved quality of life outcomes.

Registry

euclinicaltrials.eu

Start Date

November 26, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Responsible Party

Principal Investigator

Rocco Antonio Montone

Scientific

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

Inclusion Criteria

•Ability to give informed consent to the study
•MINOCA diagnosis, defined as: - Acute myocardial infarction (based on Fourth Universal Definition of Myocardial Infarction Criteria): - Evidence of non-obstructive coronary artery disease on angiography (i.e., no coronary artery stenosis >50%) in any major epicardial vessel. - No specific alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis).

Exclusion Criteria

•Inability or limited capacity to give informed consent to the study
•Pregnant and breast-feeding women or patients considering becoming pregnant during the study period will be excluded. For women of childbearing potential, the use of a highly effective contraceptive measure is required in order to be included in the study. “Highly effective contraceptive” is defined in accordance with the recommendations of the Clinical Trial Facilitation Group as a contraceptive measure with a failure rate of less than 1% per year (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf).
•Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, valve disease, hypertrophic cardiomyopathy and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded
•Contraindication to contrast-enhanced CMR, eg, severe renal dysfunction (glomerular filtration rate <30 mL/min), non–CMR-compatible pacemaker or defibrillator
•Contraindication to drugs administrated: e.g a history of hypersensitivity to drugs administrated or its excipients, significant renal and/or hepatic disease
•Patients with comorbidities having an expected survival <1-year will be excluded

Outcomes

Primary Outcomes

Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up in patients with MINOCA

Secondary Outcomes

Rates of major adverse cardiovascular events (MACE; composite of all-cause mortality; re-hospitalization for myocardial infarction, stroke or heart failure; repeated coronary angiography) at 1-year follow-up in MINOCA patients
Healthcare primary and secondary related-costs (including costs for tests, procedures and outpatient visits or medicines) and socioeconomic burden of MINOCA patients
Ability of different circulating biomarkers (ET-1, NPY, CRP, sCD40L and miRNA [miR-16, miR-26a, miR-145, miR-222, miR-155-5p, miR-483-5p and miR-451]) as diagnostic biomarker and stratification tool for specific causes of MINOCA
Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value