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

NCT07103317 | Recruiting

• 1 other identifier: EK -151.42/25
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ANOCA; ANOCA - Angina With Non-obstructive Coronary Arteries; MINOCA; Microvascular Dysfunction; Microvascular Angina; Vasospastic Angina; Acetylcholine

Keywords

ANOCA; INOCA; MINOCA; Coronary Microvascular Dysfunction; Microvascular Angina; Vasospastic Angina; Acetylcholine Testing; Coronary Termodilution

Outcome Measures

Primary Outcomes (2)

• All-cause death

  All-cause death

  1 year

• Components of MACE

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

  1 year

Other Outcomes (2)

• Angina severity

  1 year

• Quality of life (EQ-5D-5L)

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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)

You may not qualify if:

• Persons under the age of 18
• Pregnant of nursing
• No coronary physiology measurements were performed

Sponsors & Collaborators

• University Hospital, Motol: lead
• 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

Study Sites (1)

University Hospital Motol

Prague, Česká Republika, 15006, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood - plasma

MeSH Terms

Conditions

MINOCA; Microvascular Angina; Angina Pectoris, Variant

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Angina, Unstable; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Petr Kala, M.D., Ph.D.

  University Hospital Motol, Charles University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petr Kala, M.D., Ph.D.

CONTACT

+420702024181; petr.kala@fnmotol.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Principal Investigator

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 5, 2025
• Study Start: April 20, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)