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NCT Number: NCT06511817

Myocardial Infarction With Non-obstructive Coronary Arteries: Italian Study

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.

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Key information

Conditions

Minoca Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Although the prevalence of MINOCA is about 5-25% of all myocardial infarctions and the prognosis is now recognised as inauspicious, with a one-year all-cause mortality rate of 3.5%, data on the specific demographics, clinical features, etiopathogenetic factors and prognosis of MINOCA patients are still currently unavailable in Italy. The aim of this study is to assess, in a real-world setting, prevalence, demographics, possible aetiological causes and diagnostic, therapeutic and prognostic data of MINOCA patients in Italy by creating a national database with ambispectively collected data. The collection of therapeutic and management data on MINOCA in an ambispective manner - retrospective and prospective patients - will make it possible to evaluate the hospital management of MINOCA and its association with patient prognosis over time. This database will serve to determine the incidence and characteristics of this pathology. In addition, it will make it possible to evaluate the nationwide management of patients with MINOCA, thus considering both the diagnostic aspects aimed at defining the aetiology, and cascade the treatments used and the patients' outcomes. As in all observational studies, the assessment of the risk/benefit ratio of patients with myocardial infarction, the administration of medical treatment and the management of the disease and treatment-related clinical events are the responsibility of the physician treating the patient. Since the purpose of the work only involves the collection of data, participation in this research will not entail any additional risk for the patient. The collection of actual data should provide valuable information on the demographics, aetiology and prognosis of MINOCA patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • Diagnosis of MINOCA;
  • Informed consent signed by the patient or parent/guardian/legal representative.

Exclusion criteria

  • Age <18 years;
  • Refusal to sign written informed consent.

Treatment and study plan

No intervention will be performed

Other

No intervention will be performed

Primary outcomes

  1. The primary endpoint is to assess the incidence of MINOCA patients in Italy, expressed as 100 person-years.

    Time frame: up to 2 years

    incidence of MINOCA patients in Italy, expressed as 100 person-years.

Secondary outcomes

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

    Time frame: up to 2 years

    assess MINOCA aetiology

  2. MACE

    Time frame: up to 8 years

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

  3. MINOCA re-hospitalization

    Time frame: up to 8 years

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

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

    Time frame: up to 8 years

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

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

    Time frame: up to 8 years

    Assess quality of life through Short Form Health Survey 36 (SF-36) questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Rocco Antonio Montone, MD, PhD

CONTACT

[email protected]

06 3015 4187

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Myocardial Infarction With Non-obstructive Coronary Arteries: Italian Observational

Acronym: MINOCA-IT

Important dates

Study start
2024
Primary completion
2026
Study completion
2032
First posted
Jul 22, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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