Ireland
--:--IST
Recruiting Observational

Myocardial Ischemia Without Obstructive Coronary Stenoses

NCT04827498 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2017-11-08
Last updated
2021-04-26

Condition(s) studied

Myocardial IschemiaNon-Obstructive Coronary AtherosclerosisMicrovascular Coronary Artery DiseaseVasospastic AnginaMyocardial Bridging

Investigational drug(s) / intervention(s)

Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment

Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment: Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire

Study summary

Coronary-related myocardial ischemia can result from obstructive epicardial stenosis or non-obstructive causes including coronary microcirculatory dysfunction and vasomotor disorders. This prospective study has been created in order to provide knowledge in the field of non-obstructive coronary artery disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Written informed consent available. * Age ≥ 18 years. * Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine. Exclusion Criteria: * Hemodynamic instability. * Anticipated technical issues for physiology wire measurements. * Culprit vessel of acute coronary syndrome * Contraindications for adenosine administration. * Contraindications for acetylcholine test. * Reduced life expectancy (less than 1 year).

Primary outcome measure(s)

  • Patient-oriented composite outcome — Up to 5 years
    Incidence of a patient-oriented composite outcome, a composite of any death, nonfatal myocardial infarction, any ischemia-driven revascularization or hospitalization due to unstable angina pectoris
  • Vessel-oriented composite outcome — Up to 5 years
    Incidence of a vessel-oriented composite outcome, a composite of cardiac death, target-vessel related myocardial infarction or target-vessel revascularization
  • Patient symptoms burden — Up to 12 months
    Change in the Seattle questionnaire of angina scoring, associated to stratified medical treatment. Minimum is 0 and maximum is 100 and lower scores indicate worse outcome

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinico San Carlos Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04827498 on ClinicalTrials.gov ↗ ← All trials in Spain