INOCA Spanish National Registry (ESP-INOCA)

INOCA Spanish National Registry: ESP-INOCA

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Eva Rumiz, MD, PhD; Phone Number: 446812 +34 963131800; Email: evarumizgonzalez@gmail.com

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario de La Princesa
    • Contact: Fernando Rivero Crespo, MD
  • Murcia, Spain
    • Recruiting
    • Hospital Universitario Virgen de Arrixaca
    • Contact: Ramón Lopez Palop, MD
  • Valencia, Spain
    • Recruiting
    • Hospital General Universitario de Valencia
    • Contact: Eva Rumiz Gonzalez, MD, PhD; Phone Number: +34 626068935; Email: evarumizgonzalez@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with angina and no obstructive coronary artery disease on coronary angiography, as well as those with angina equivalent symptoms and ischaemia on non-invasive tests (exercise stress test, cardiac magnetic resonance imaging, stress echocardiography, SPECT) in the absence of obstructive coronary artery disease, will be prospectively included. They must have undergone an invasive coronary function test. The absence of obstructive coronary artery disease will be defined as the presence of stenosis with a diameter <50% or >/= 50% and a negative functional test.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of INOCA endotypes.	To determine the prevalence of the different INOCA endotypes in our setting through a nationwide registry.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department.	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.	24 months
Targeted pharmacological treatment	To determine the impact of targeted pharmacological treatment in INOCA patients.	24 months
Prognostic markers.	To identify prognostic markers.	24
INOCA and risk of heart failure with preserved ejection fraction.	To evaluate the association between INOCA patients and the development of heart failure with preserved ejection fraction.	24 months

Collaborators and Investigators

• Sponsor: Eva Rumiz González
• Collaborators: Hospital Clinic of Barcelona; Hospital General Universitario Elche; Hospital Universitario Ramon y Cajal; Hospital de Basurto; Hospital Universitari de Bellvitge; Hospital Universitario Virgen de la Arrixaca; Hospital Universitario 12 de Octubre; Puerta de Hierro University Hospital; Hospital Universitario La Fe; Hospital de Manises; University of Salamanca; Hospital Virgen de la Salud; Hospital Universitario Fundación Jiménez Díaz; Hospital San Carlos, Madrid; Hospital Universitario La Paz; Fundación de Investigación Biomédica - Hospital Universitario de La Princesa; Hospital Universitario San Juan de Alicante; Hospital Miguel Servet; Hospital Universitario Marqués de Valdecilla; Complexo Hospitalario Universitario de A Coruña; University Hospital of the Nuestra Señora de Candelaria; Hospital General Universitario de Alicante; Hospital Clinico Universitario de Santiago; Hospital Universitario Puerta del Mar; Hospital Clínico Universitario de Valladolid; Hospital Universitario Donostia; Hospital Universitario de Torrevieja; Hospital Clínico Universitario Lozano Blesa; Complejo Hospitalario Universitario de Huelva; Hospital General Universitario de Castellón; Hospital Clínico Universitario de Valencia; Hospital de la Ribera; University Hospital Gregorio Marañón; Hospital de la Santa creu i Sant Pau - Barcelona; Hospital Universitario Virgen del Rocio

Study record dates

Study Major Dates

• Study Start (Estimated): March 24, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Myocardial ischemia; Microvascular dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Atherosclerosis
• Other Study ID Numbers: 162023

Drug and device information, study documents

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