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

NCT07337005 | Not Yet Recruiting

• 1 other identifier: IRAS 356198
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Feasibility outcome

  Proportion of patients in whom the full invasive protocol (baseline and post-stimulation measurements) is successfully completed without major technical issues or protocol deviations.

  At baseline

Secondary Outcomes (5)

• Reproducibility outcome

  At baseline

• Safety outcome

  At Baseline and up to 12 months

• Correlation between invasive and non-invasive measures of endothelial-dependent coronary microvascular dysfunction.

  From baseline and up to 3 months

• Correlation between invasive physiological indices of coronary microvascular function and symptom burden at baseline.

  Baseline (at time of invasive coronary function testing).

• Change in symptoms, quality of life, and need for further investigation or treatment during follow-up.

  From baseline to 12 months follow-up

Study Arms (1)

Invasive Coronary function Assessment arm

EXPERIMENTAL

Invasive coronary endothelial function and vasospasm assessment

Procedure: Invasive coronary physiological measurements

Interventions

Invasive coronary physiological measurements 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.

Invasive Coronary function Assessment arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead

MeSH Terms

Conditions

Coronary Vasospasm

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 13, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2025-12