Myocardial Infarction With Non-obstructive Coronary Arteries: Italian Study

NCT06511817 | Not Yet Recruiting

• 1 other identifier: 6472
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MINOCA

Outcome Measures

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.

  up to 2 years

Secondary Outcomes (5)

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

  up to 2 years

• MACE

  up to 8 years

• MINOCA re-hospitalization

  up to 8 years

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

  up to 8 years

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

  up to 8 years

Interventions

No intervention will be performed OTHER

No intervention will be performed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

MINOCA

Condition Hierarchy (Ancestors)

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

Study Officials

• Rocco Antonio Montone

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocco Antonio Montone, MD, PhD

CONTACT

06 3015 4187; roccoantonio.montone@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 22, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2032
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

IT (1)