Myocardial Infarction With Non-obstructive Coronary Arteries: Italian Study
NCT Number: NCT06511817
Acronym: MINOCA-IT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: MINOCA
Interventions: OTHER: No intervention will be performed
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2032-12-30
Locations: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, 00168, Italy

Summary:
Acute coronary syndromes have been extensively studied in recent decades, focusing mainly on myocardial infarctions with obstructive coronary artery disease and early revascularisation strategies. However, the extensive use of highly sensitive troponin tests and coronary angiography has revealed a substantial group of patients with myocardial infarction without significant coronary stenosis (≥50%). This group is referred to as myocardial infarction with non-obstructive coronary arteries (MINOCA). MINOCA are defined by evidence of a myocardial infarction with normal or near-normal coronary arteries on angiography, in the absence of an alternative diagnosis specific to the clinical presentation (e.g. sepsis, myocarditis, pulmonary embolism). MINOCA may present with different aetiologies, including coronary plaque rupture/erosion, epicardial or microvascular spasm and coronary embolism. Therefore, the diagnosis of MINOCA must be considered a 'working diagnosis', which not only requires but warrants further investigation to determine the underlying cause. In fact, the investigation of MINOCA is conducted on two levels, first by excluding disorders that mimic myocardial infarction and then by identifying the cause responsible for MINOCA. In order to identify the various underlying causes of MINOCA, a cardiac MRI and/or coronary vascular imaging approach with OCT or intravascular ultrasound (IVUS) and a coronary functional assessment of microvascular function, as well as the provocation of coronary spasms by acetylcholine testing are recommended. Moreover, the clear definition of the aetiology is of great importance considering the role they play in the most appropriate therapeutic choice.

Therefore, the creation of an Italian national database could implement not only the knowledge of this clinical condition but also its management and consequent prognosis.

Primary Outcome Measures: The primary endpoint is to assess the incidence of MINOCA patients in Italy, expressed as 100 person-years., incidence of MINOCA patients in Italy, expressed as 100 person-years., up to 2 years
Secondary Outcome Measures: To assess in real-world setting the characteristics of MINOCA patients, assess MINOCA aetiology, up to 2 years|MACE, To assess MINOCA MACE prognostic factors at 12 months followup and up to 60 months., up to 8 years|MINOCA re-hospitalization, To assess MINOCA re-hospitalization prognostic factors at 12 months followup and up to 60 months., up to 8 years|To assess change in symptoms and quality of life through a questionnaire., Assess quality of life through Seattle Angina Questionnaire (SAQ) questionnaires, up to 8 years|To assess change in symptoms and quality of life through a questionnaire., Assess quality of life through Short Form Health Survey 36 (SF-36) questionnaires, up to 8 years