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

Phase 1

• Conditions: Patients with Myocardial Infarction and non-obStructive coronary artEries; MedDRA version: 20.0Level: HLTClassification code 10011085Term: Ischaemic coronary artery disordersSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-006009-43-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

•Ability to give informed consent to the study
•Age > 18y
•MINOCA diagnosis, defined as:
oAcute myocardial infarction (based on Fourth Universal Definition of Myocardial Infarction Criteria):
oEvidence of non-obstructive coronary artery disease on angiography (i.e., no coronary artery stenosis >50%) in any major epicardial vessel.
oNo specific alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Inability or limited capacity to give informed consent to the study
•Age < 18 y
•Alternate diagnosis for the clinical presentation (i.e. non-ischemic causes of myocardial injury such as sepsis, pulmonary embolism, and myocarditis). Also patients presenting with Takotsubo syndrome will be excluded.
•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
Main Objective: •To test if a precision-medicine approach with a careful investigation of the MINOCA aetiology and consequent aetiology-based treatment may result in improved cardiovascular and quality of life outcomes, as well as in reduced healthcare related costs.;Secondary Objective: . To test wherever a plasma circulating biomarker profile may be able to differentiate between the different causes of MINOCA, helping to identify the underlying pathophysiological mechanisms and to stratify prognosis and response to medical therapy.<br>• To test wherever cardiac magnetic resonance (CMR) may provide a morphological and functional cardiac characterization as well as help in the prognostic stratification in MINOCA.;Primary end point(s): Angina status and quality of life (evaluated using the Seattle Angina Questionnaire [SAQ]) at 1-year follow-up;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: 1 YEAR