CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction (REDEFINE-CMD)

Mid and South Essex NHS Foundation Trust

Status: Not yet enrolling

Conditions: Vasospasm, Coronary; Coronary Microvascular Dysfunction (CMD)

Treatments: Procedure: Invasive coronary physiological measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT07337005

IRAS 356198

Details and patient eligibility

About

The goal of this observational study is to learn more about the diagnosis of coronary endothelium function and coronary vasospasm using a dedicated invasive protocol in patients who has angina without obstruction in their main heart arteries. The main question it aims to answer is the feasibility, reproducibility, and safety of this invasive protocol:

Does this invasive protocol diagnose coronary endothelial dysfunction and vasospasm without issues?

Participants already having invasive coronary angiogram and physiological studies will undergo additional physiological measurements during the same procedure.

Participants will enrol in a symptoms and quality of life questionnaire using dedicated questionnaires and a mobile application to assess the burden of their symptoms before and after the invasive procedure and up to 12 months follow up.

A subset of participants will undergo a repeat set of these measurements to assess reproducibility of the invasive protocol.

A subset of the participants will also undergo a cardiac MRI to assess correlation with the invasive protocol measurements.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with symptoms suggestive of angina.
2. Evidence of unobstructed coronary arteries on invasive or non-invasive coronary angiography (coronary stenosis <50% and /or FFR >0.80).
3. Above the age of 18.
4. The subject has been informed of the nature of the study, agrees to its provisions and has signed written informed consent.

Exclusion criteria

1. Pregnancy.
2. Contraindication to angiography and/or physiological assessment with adenosine or acetylcholine.
3. Previous coronary artery bypass graft (CABG).
4. Moderate to severe valvular heart disease.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Invasive Coronary function Assessment arm

Experimental group

Description:

Invasive coronary endothelial function and vasospasm assessment

Treatment:

Procedure: Invasive coronary physiological measurements