Comprehensive Coronary Physiology in Patients With Angina With Nonobstructive Coronary Arteries - Czech Republic

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Motol

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

All-cause death

All-cause death

Time frame
1 year
2

Components of MACE

Cardiovascular death, MI, coronary revascularisation, stroke, hospitalization for heart failure, hospitalization for acute coronary syndrome, repeated coronary angiography

Time frame
1 year

Secondary outcomes

Other outcomes

1

Angina severity

Seattle Angina Questionnaire - SAQ - 0 to 100 - the higher the less symptoms \- change in SAQ score from baseline

Time frame
1 year
2

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

Time frame
1 year

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