Myocardial Infarction With Non-obstructive Coronary Arteries: Italian Study (MINOCA-IT)

Myocardial Infarction With Non-obstructive Coronary Arteries: Italian Observational

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.

Study Overview

• Status: Not yet recruiting
• Conditions: MINOCA
• Intervention / Treatment: Other: No intervention will be performed

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Rocco Antonio Montone, MD, PhD; Phone Number: 06 3015 4187; Email: roccoantonio.montone@unicatt.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Rocco Antonio Montone; Phone Number: +390630154187; Email: roccoantonio.montone@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Rocco Antonio Montone, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2032

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; MINOCA
• Other Study ID Numbers: 6472

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No