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INOCA Spanish National Registry

INOCA Spanish National Registry: ESP-INOCA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06327672
Acronym
ESP-INOCA
Enrollment
1000
Registered
2024-03-25
Start date
2024-03-24
Completion date
2026-03-31
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Ischemia, Non-Obstructive Coronary Atherosclerosis

Keywords

Microvascular dysfunction, Endothelial dysfunction, Myocardial ischemia

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of INOCA endotypes.12 monthsTo determine the prevalence of the different INOCA endotypes in our setting through a nationwide registry.

Secondary

MeasureTime frameDescription
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 monthsTo 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.
Targeted pharmacological treatment24 monthsTo determine the impact of targeted pharmacological treatment in INOCA patients.
Prognostic markers.24To identify prognostic markers.
INOCA and risk of heart failure with preserved ejection fraction.24 monthsTo evaluate the association between INOCA patients and the development of heart failure with preserved ejection fraction.

Countries

Spain

Contacts

Primary ContactEva Rumiz, MD, PhD
evarumizgonzalez@gmail.com+34 963131800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026