NCT07337005

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mid and South Essex NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2026-01-13
• Last updated: 2026-01-13