A Study of Pressure Waveform Analysis in Coronary Artery-II

Ischemic Heart Disease Clinical Trial

Official title:

A Study of Pressure Waveform Analysis in Coronary Artery-II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672706
• Other study ID #: 111-129-E
• Status: Recruiting
• Start date: January 4, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2023
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Chien-Boon Jong, MD
• Phone: 035322140
• Email: jgboon0407[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• CFR and IMR group
Participants will undergo repeat intracoronary adenosine administration during CFR and IMR measurement

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsin-Chu branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeatability of CFR and IMR value	To compare the difference of individual value, while repeat the measurement within 1 minutes	10 minutes
Secondary	Major adverse cardiovascular outcomes	Including death, myocardial infarction, stroke and heart failure	3 year