About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent available.
Age ≥ 18 years.
Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine.
Disqualifiers
Hemodynamic instability.
Anticipated technical issues for physiology wire measurements.
Culprit vessel of acute coronary syndrome
Contraindications for adenosine administration.
Trial population
The target population consists of patients with clinically indicated invasive physiological measures of coronary pressure and flow with adenosine and acetylcholine for the assessment of myocardial ischemia.
Trial design
Cohort
Prospective
Treatments tested in this trial
Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment
Diagnostic testCoronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire
Treatment groups
Trial outcomes
Primary outcomes
Patient-oriented composite outcome
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
Incidence of a vessel-oriented composite outcome, a composite of cardiac death, target-vessel related myocardial infarction or target-vessel revascularization
Patient symptoms burden
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
Secondary outcomes
Cumulative incidence of any death
Cumulative incidence of cardiac death
Cumulative incidence of nonfatal myocardial infarction
Cumulative incidence of ischemia-driven revascularization
Other outcomes
Resting and hyperemic mean aortic pressure (mmHg)
Measured with the coronary guiding catheter during physiology assessment under adenosine administration and acetylcholine provocation test
Resting and hyperemic mean intracoronary distal pressure (mmHg)
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Resting and hyperemic mean coronary flow (mean transit time or cms/sec)
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Resting and hyperemic coronary microcirculatory resistance (units)
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Sponsors and contacts
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Hospital San Carlos, Madrid
Lead sponsor
Fundacion Investigacion Interhospitalaria Cardiovascular
Collaborator