INOCA Spanish National Registry

Coronary Disease Clinical Trial

— ESP-INOCA  

Official title:

INOCA Spanish National Registry: ESP-INOCA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06327672
• Other study ID #: 162023
• Status: Recruiting
• Start date: March 24, 2024
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: Hospital General Universitario de Valencia
• Contact: Eva Rumiz, MD, PhD
• Phone: +34 963131800
• Email: evarumizgonzalez[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia
• Non-Obstructive Coronary Atherosclerosis

Locations

Country	Name	City	State
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Virgen de Arrixaca	Murcia
Spain	Hospital General Universitario de Valencia	Valencia

Sponsors (36)

Lead Sponsor

Collaborator

Eva Rumiz González

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of INOCA endotypes.	To determine the prevalence of the different INOCA endotypes in our setting through a nationwide registry.	12 months
Secondary	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
Secondary	Targeted pharmacological treatment	To determine the impact of targeted pharmacological treatment in INOCA patients.	24 months
Secondary	Prognostic markers.	To identify prognostic markers.	24
Secondary	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