INOCA Spanish National Registry

Recruiting

• Conditions: Coronary Disease; Non-Obstructive Coronary Atherosclerosis; Ischemia

• Registration Number: NCT06327672
• Lead Sponsor: Eva Rumiz González

Brief Summary

Coronary atherosclerosis is the most common cause of ischaemic heart disease. About 40-50% of patients with symptoms and documented ischaemia on non-invasive tests do not show obstructive coronary artery disease on coronary angiography. This cause of ischaemic heart disease called INOCA (Ischemic Non-Obstructive Coronary Artery), far from having a benign prognosis, is associated with an increase in major adverse cardiac events (MACE) as well as increased functional limitation. The current European Society of Cardiology clinical practice guidelines for the management of chronic coronary syndrome establish for the first time a IIa recommendation for the invasive analysis of coronary flow reserve (CFR) and microvascular resistance index (MRI) in symptomatic patients with INOCA. The acetylcholine (Ach) test, based on intracoronary (ic) administration, is established as indication IIb for the assessment of micro or macrovascular vasospasm in patients with suspected vasospastic angina (VSA) (4). A national multicentre registry would allow us to determine the prevalence of INOCA and its different endotypes in our setting.

Detailed Description

Multicentre, observational, longitudinal, prospective study on INOCA patients undergoing invasive coronary function testing.

Microvascular angina (MVA) is defined according to the standardized diagnostic criteria of COVADIS (Coronary Vasomotion Disorders International Study Group): symptoms of myocardial ischaemia, unobstructed coronary arteries and demonstrated coronary microvascular dysfunction (CFR \< 2 and/or IMR \>25), or microvascular spasm on Ach test. Diagnosis of coronary microvascular spasm requires provocation and reproduction of symptoms, ischaemic EKG changes, in the absence of epicardial spasm during ACh testing. The diagnosis of VSA requires that 3 conditions are met during ACh testing: 1) clinically significant epicardial vasoconstriction (≥90%); 2) reproduction of chest pain; and 3) ischaemic EKG changes.

Definition of adverse events: Myocardial infarction (MI) will be defined according to the fourth universal definition and subclassified according to type. Ischaemia revascularization will be defined as all percutaneous coronary intervention (PCI) or Coronary Artery Bypass Grafting (CABG) occurring after the baseline procedure and justified by recurrent symptoms or objective evidence of significant ischaemia on non-invasive stress tests. Heart failure will be defined as a hospital admission \> 24 hours with any of the following symptoms and signs: worsening dyspnea, fatigue, fluid overload, pulmonary oedema, elevated venous pressure and need for intravenous diuretics or inotropics. Visits to the emergency department for chest pain will be considered to be those in which there is suspicion of a coronary cause.

All events will be identified and quantified from patient records, including inpatient ward admissions and emergency department visits.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study Start: 2024-03-24
• Study First Posted: 2024-03-25
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients > 18 years.
• Anginal symptoms.
• Anginal equivalent with positive myocardial ischaemia test.
• Absence of obstructive coronary artery disease (diameter stenosis <50% or >50% with a FFR>0.80).
• Patients undergoing invasive coronary function test.
• Signed informed consent.

Exclusion Criteria

• Failure to meet inclusion criteria.
• Patients with moderate-severe valvular heart disease.
• Patients with structural heart disease.
• Elevation of markers of myocardial necrosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of INOCA endotypes.	12 months	To determine the prevalence of the different INOCA endotypes in our setting through a nationwide registry.

Secondary Outcome Measures

Name	Time	Method
Incidence of combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department.	24 months	To determine the long-term prognosis of the different INOCA subtypes, through analysis of the combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department.
Prognostic markers.	24	To identify prognostic markers.
Targeted pharmacological treatment	24 months	To determine the impact of targeted pharmacological treatment in INOCA patients.
INOCA and risk of heart failure with preserved ejection fraction.	24 months	To evaluate the association between INOCA patients and the development of heart failure with preserved ejection fraction.

Trial Locations

Locations (3)

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Virgen de Arrixaca; 🇪🇸 Murcia, Spain