A Study of Pressure Waveform Analysis in Coronary Artery-II

Recruiting

• Conditions: Ischemic Heart Disease
• Interventions: Procedure: CFR and IMR group

• Registration Number: NCT05672706
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Brief Summary

The goal of this observational study is to test the feasibility of intracoronary adenosine administration during coronary flow reserve(CFR) and index of microcirculatory resistance(IMR) assessment in a population with angina. The main questions it aims to answer are:

* Repeatability of CFR and IMR assessment while hyperemia with intracoronary adenosine was administered.

* Evaluate the correlation of the intrinsic signal of coronary waveform versus physiologic ischemia, while defined by fractional flow reserve(FFR) and CFR respectively.

* The predictive value of FFR, CFR, and IMR on major adverse cardiovascular outcomes in 3 years Participants will undergo FFR, CFR, and IMR assessments in the catheterization laboratory of the National Taiwan University Hospital Hsin-Chu Branch, then clinical events follow up for 3 years.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Last Update Submitted: 2023-01-03
• Study Start: 2023-01-04
• Study First Posted: 2023-01-05
• Last Update Posted: 2023-01-05
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Participants with angina

Exclusion Criteria

• Severe valvular heart disease
• History of asthma
• Heart rate less than 50 beats per minute
• systolic blood pressure less than 90 mmHg

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CFR and IMR group	CFR and IMR group	-

Primary Outcome Measures

Name	Time	Method
Repeatability of CFR and IMR value	10 minutes	To compare the difference of individual value, while repeat the measurement within 1 minutes

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular outcomes	3 year	Including death, myocardial infarction, stroke and heart failure

Trial Locations

Locations (1)

National Taiwan University Hospital Hsin-Chu branch; 🇨🇳 Hsinchu, Taiwan