NCT03477890Active, not recruiting
Coronary Microvascular Function and CT Coronary Angiography (CorCTCA)
Angina in Patients Without Obstructive Coronary Disease as Revealed by CT Coronary Angiography (Cor-CTCA): an Observational Cohort Study Involving Coronary Function Tests and a Nested Randomised Trial
Source: ClinicalTrials.gov · Last updated 29 Oct 2024
Brief summary (registry, in English)
Angina in patients without obstructive coronary artery disease (CAD) is a clinical conundrum and patient management is heterogeneous. Hypothesis: Abnormal coronary function is common and clinically relevant in this population. Design: An observational cohort study and nested randomised controlled diagnostic strategy trial. Methods: 250 patients with known or suspected angina informed by validated questionnaires but without obstructive CAD (\<70% stenosis) in an artery \>=2.5 mm or structural heart disease, as revealed by CT coronary angiography (CTCA), will be invited to undergo coronary function testing (FFR, CFR, IMR; intra-coronary ACh) during invasive angiography. Patients will be randomised following angiography but before testing coronary function to disclosure of the coronary function test results or not. Treatment decisions by the attending cardiologist will be recorded before and after disclosure of results. Outcomes: Primary: The between-group difference in the reclassification rate of the initial diagnosis using logistic regression, adjusted for baseline factors associated with the likelihood of reclassification of the initial diagnosis. Secondary: Prevalence of microvascular or vasospastic angina; health status reflected by the EuroQol group 5-Dimensions (EQ-5D), Seattle Angina Questionnaire, Illness perception, treatment satisfaction questionnaires and functional status questionnaires; angina medication and adherence. Value: This research will provide new insights into the conundrum of angina in patients without obstructive CAD or structural heart disease.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 6 Oct 2017
- Start date
- 31 Aug 2017
- Primary completion date
- 20 Dec 2023
- Lead sponsor
- NHS National Waiting Times Centre Board
- Diseases
- Coronary artery disease
- NCT number
- NCT03477890
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 31 Aug 2017 to the primary completion date, 20 Dec 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A health problem that would explain the angina, e.g. anaemia, moderate-severe aortic stenosis, hypertrophic obstructive cardiomyopathy
- Obstructive disease evident in a coronary artery (diameter \>2.5 mm), i.e. \>50 - 70% circumferential plaque extending for ≥2 coronary segments, or a stenosis\>70% as revealed by CT coronary angiography
- Flow-limiting coronary disease defined by a fractional flow reserve (FFR) ≤0.80 in an artery\>2.5 mm.
Lab values
- Lack of informed consent.
- Exclusion from randomisation in the catheter laboratory:
Who the study is looking for
- Symptoms of angina or angina-equivalent informed by the Rose Angina questionnaire.
- Intermediate or no obstructive coronary disease i.e. no coronary stenosis \>70% in an artery \>2.5 mm, as revealed by CT coronary angiography.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Golden Jubilee National Hospital Coordinator of this site? Confirm its status | Clydebank | United Kingdom | Unknown status |
| Glasgow Royal Infirmary Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Forth Valley Royal Hospital Coordinator of this site? Confirm its status | Larbert | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.