CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction

NCT ID: NCT07337005

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Coronary Microvascular Dysfunction (CMD); Vasospasm, Coronary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Invasive Coronary function Assessment arm

Invasive coronary endothelial function and vasospasm assessment

Group Type: EXPERIMENTAL

Invasive coronary physiological measurements

Intervention Type: PROCEDURE

Invasive assessment of changes in coronary blood flow, resistance, and distal pressure in response to acetylcholine infusion. These will be measured during a clinical indicated invasive coronary angiogram procedure and physiological studies using a standard coronary pressure wire and a dedicated infusion catheter.

Interventions

Invasive coronary physiological measurements

Invasive assessment of changes in coronary blood flow, resistance, and distal pressure in response to acetylcholine infusion. These will be measured during a clinical indicated invasive coronary angiogram procedure and physiological studies using a standard coronary pressure wire and a dedicated infusion catheter.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRAS 356198

Identifier Type: -

Identifier Source: org_study_id