PROgnostic value of precision medicine in patients with Myocardial Infarction and non-obStructive coronary artEries: the PROMISE study
- Conditions
- Myocardial infarction with non-obstructive coronary arteries (MINOCA)
- Registration Number
- 2024-518724-72-00
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 145
Ability to give informed consent to the study
Age > 18y
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).
Inability or limited capacity to give informed consent to the study
Age < 18 y
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up in patients with MINOCA Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up in patients with MINOCA
- Secondary Outcome Measures
Name Time Method 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 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 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 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 Ability of CMR in evaluating different mechanisms of MINOCA and their prognostic value
Trial Locations
- Locations (4)
Policlinico San Donato S.p.A.
🇮🇹San Donato Milanese, Italy
University Hospital Of Ferrara
🇮🇹Ferrara, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Rome, Italy
Centro Cardiologico Monzino S.p.A.
🇮🇹Milan, Italy
Policlinico San Donato S.p.A.🇮🇹San Donato Milanese, ItalyRiccardo GorlaSite contact3428732190riccardo.gorla@grupposandonato.it