About this trial
Coronary artery disease (CAD) is a leading cause of morbidity and mortality. While cardiologists have been focused on discrete, visible stenoses of coronary arteries, there is increasing awareness of the importance of microcirculation and vasospastic disorders in causing angina. The microvascular bed is composed of vessels smaller than 400 microns in diameter. Their network is significantly larger than that of the epicardial vessels and serves essential functions, including regulating myocardial blood flow and cellular metabolism.
Angina pectoris, a most frequent symptom of CAD or myocardial ischemia, was assumed to be caused by significant stenosis of the epicardial coronary artery. However, it was found that in over 50% of cases, there was no obstructive CAD, which is described as angina with no obstructive coronary arteries (ANOCA) or ischemia with no obstructive coronary arteries (INOCA), according to the clinical setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults of both sexes older than 18 years
Angina symptoms or angina equivalent
Referred to cath lab for evaluation of CAD
Invasive physiology testing performed (microcirculation testing +/- vasospasm testing)
Disqualifiers
Persons under the age of 18
Pregnant of nursing
No coronary physiology measurements were performed
Trial population
The prospective and observational study will include patients who underwent microcirculation assessment or vasospastic testing using intracoronary Ach (or both as parts of CFT). As described above, participants will undergo routine coronary angiography and comprehensive physiologic testing by coronary thermodilution to evaluate CMD and provocative Ach testing for diagnosing vasospastic angina (VSA).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
All-cause death
All-cause death
Components of MACE
Cardiovascular death, MI, coronary revascularisation, stroke, hospitalization for heart failure, hospitalization for acute coronary syndrome, repeated coronary angiography
Other outcomes
Angina severity
Seattle Angina Questionnaire - SAQ - 0 to 100 - the higher the less symptoms \- change in SAQ score from baseline
Quality of life (EQ-5D-5L)
EQ-5D-5L questionnaire; -0.59 to 1, where 1 is the best possible health state \- change in EQ-5D-5L score from baseline
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Motol
Lead sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborator
Nemocnice AGEL Trinec-Podlesi a.s.
Collaborator
Brno University Hospital
Collaborator
Institute for Clinical and Experimental Medicine
Collaborator