Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06327672
Study type Observational [Patient Registry]
Source Hospital General Universitario de Valencia
Contact Eva Rumiz, MD, PhD
Phone +34 963131800
Email evarumizgonzalez@gmail.com
Status Recruiting
Phase
Start date March 24, 2024
Completion date March 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Completed NCT05672862 - International Post-PCI FFR Extended Registry
Completed NCT04492423 - VerifyNow® PRUTest® Cardiovascular Population Expected Values On-Drug Study
Completed NCT01205776 - EXCEL Clinical Trial N/A
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed NCT00046410 - Comparison of the Risk of Stroke With On- Versus Off-Pump Coronary Artery Bypass Grafting N/A
Recruiting NCT04390672 - Multivessel TALENT N/A
Completed NCT02948517 - Time Restricted Feeding for Weight Loss and Cardio-protection N/A
Completed NCT02784873 - High Intensity Interval Training in UK Cardiac Rehabilitation Programmes N/A
Not yet recruiting NCT02895009 - Hemostatic Compression Patterns After Transradial Coronary Intervention N/A
Recruiting NCT02859480 - Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI Phase 4
Completed NCT02510547 - Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial Phase 4
Withdrawn NCT02418143 - A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope
Completed NCT02382731 - Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction N/A
Recruiting NCT01681381 - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization N/A
Completed NCT02248415 - Administration of Warm Blood Cardioplegia With or Without Roller Pump N/A
Recruiting NCT01207167 - Mediators of Atherosclerosis in South Asians Living in America
Completed NCT02088138 - Functional Electrical Stimulation in Cardiac Patients N/A
Completed NCT02133807 - Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis Phase 3
Completed NCT02173067 - Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective N/A