Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-03-24
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
* Patients with moderate-severe valvular heart disease.
* Patients with structural heart disease.
* Elevation of markers of myocardial necrosis.
18 Years
ALL
No
Sponsors
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Hospital San Carlos, Madrid
OTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Hospital Universitario Virgen de la Arrixaca
OTHER
University Hospital Gregorio Marañón
OTHER
Hospital Clínico Universitario de Valladolid
OTHER
Hospital Universitario Puerta del Mar
OTHER
Hospital Universitari de Bellvitge
OTHER
Hospital Universitario La Fe
OTHER
Hospital Clínico Universitario de Valencia
OTHER
Hospital Universitario La Paz
OTHER
Hospital General Universitario de Alicante
OTHER
Complejo Hospitalario Universitario de Huelva
OTHER
Hospital General Universitario de Castellón
OTHER
Hospital de Manises
OTHER
Hospital Clinic of Barcelona
OTHER
Hospital Miguel Servet
OTHER
Hospital Clínico Universitario Lozano Blesa
OTHER
Hospital Donostia
OTHER
Hospital General Universitario Elche
OTHER
Hospital Universitario Virgen del Rocio
UNKNOWN
Hospital de la Ribera
OTHER
Hospital de la Santa creu i Sant Pau - Barcelona
OTHER
Hospital Virgen de la Salud
OTHER
Hospital Universitario San Juan de Alicante
OTHER
Hospital Universitario de Torrevieja
UNKNOWN
University Hospital of the Nuestra Señora de Candelaria
OTHER
Hospital de Basurto
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Universitario Fundación Jiménez Díaz
OTHER
Puerta de Hierro University Hospital
OTHER
Hospital Universitario 12 de Octubre
OTHER
University of Salamanca
OTHER
Hospital Universitario Marqués de Valdecilla
OTHER
Hospital Clinico Universitario de Santiago
OTHER
Complexo Hospitalario Universitario de A Coruña
OTHER
Eva Rumiz González
OTHER
Responsible Party
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Eva Rumiz González
Principal Investigator
Locations
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Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Virgen de Arrixaca
Murcia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Fernando Rivero Crespo, MD
Role: primary
Ramón Lopez Palop, MD
Role: primary
References
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Rumiz E, Rivero F, Perez A, Nau G, Romero M, Solana S, Jurado A, Fuertes G, Pardo A, Gutierrez-Barrios A, Casanova J, Oteo JF, Frutos A, Salvatella N, Cardenal R, Sabatel F, Cortes C, Valero E, Rodriguez R, Gutierrez E, Lopez-Palop R, Escaned J. ESP-INOCA: Rationale and design of a national multicentre registry for prognostic stratification in patients with suspected myocardial ischaemia and non-obstructive coronary arteries. Int J Cardiol. 2025 Aug 29;442:133845. doi: 10.1016/j.ijcard.2025.133845. Online ahead of print.
Other Identifiers
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162023
Identifier Type: -
Identifier Source: org_study_id
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