About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
Diagnosis of MINOCA;
Informed consent signed by the patient or parent/guardian/legal representative.
Disqualifiers
Age <18 years;
Refusal to sign written informed consent.
Trial population
Consecutive consenting patients over 18 years of age diagnosed with myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction and undergoing diagnostic coronary angiography and without obstructive CAD (\<50%) will be included in the study from university, public and private hospitals. Patients will be included in the study by evaluating both previous patients admitted within the last 2 years (from January 2021) and consecutive patients from all centres with myocardial infarction and undergoing diagnostic coronary angiography.
Trial design
Cohort
Other
Treatments tested in this trial
No intervention will be performed
Other interventionNo intervention will be performed
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
To assess in real-world setting the characteristics of MINOCA patients
assess MINOCA aetiology
MACE
To assess MINOCA MACE prognostic factors at 12 months followup and up to 60 months.
MINOCA re-hospitalization
To assess MINOCA re-hospitalization prognostic factors at 12 months followup and up to 60 months.
To assess change in symptoms and quality of life through a questionnaire.
Assess quality of life through Seattle Angina Questionnaire (SAQ) questionnaires
Sponsors and contacts
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