Myocardial Infarction With Non-obstructive Coronary Arteries: Italian Study

ConditionMINOCA
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • No intervention will be performed

    Other intervention

    No intervention will be performed

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 2 years

Secondary outcomes

1

To assess in real-world setting the characteristics of MINOCA patients

assess MINOCA aetiology

Time frame
up to 2 years
2

MACE

To assess MINOCA MACE prognostic factors at 12 months followup and up to 60 months.

Time frame
up to 8 years
3

MINOCA re-hospitalization

To assess MINOCA re-hospitalization prognostic factors at 12 months followup and up to 60 months.

Time frame
up to 8 years
4

To assess change in symptoms and quality of life through a questionnaire.

Assess quality of life through Seattle Angina Questionnaire (SAQ) questionnaires

Time frame
up to 8 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: