Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:33 PM
Study NCT ID:
NCT07337005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction
Sponsor:
Mid and South Essex NHS Foundation Trust
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDEFINE-CMD
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: