A Study of Pressure Waveform Analysis in Coronary Artery-II

Sponsor

National Taiwan University Hospital Hsin-Chu Branch (Other)

Overall Status

Recruiting

CT.gov ID

NCT05672706

Collaborator

(none)

Enrollment

Location

59.9

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease	Procedure: CFR and IMR group

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Study of Pressure Waveform Analysis in Coronary Artery-II

Anticipated Study Start Date :

Jan 4, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
CFR and IMR group	Procedure: CFR and IMR group Participants will undergo repeat intracoronary adenosine administration during CFR and IMR measurement

Arm

Intervention/Treatment

CFR and IMR group

Procedure: CFR and IMR group

Participants will undergo repeat intracoronary adenosine administration during CFR and IMR measurement

Outcome Measures

Primary Outcome Measures

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

Major adverse cardiovascular outcomes [3 year]
Including death, myocardial infarction, stroke and heart failure

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital Hsin-Chu branch	Hsinchu		Taiwan	300

Sponsors and Collaborators

National Taiwan University Hospital Hsin-Chu Branch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital Hsin-Chu Branch

ClinicalTrials.gov Identifier:

NCT05672706

Other Study ID Numbers:

111-129-E

First Posted:

Jan 5, 2023

Last Update Posted:

Jan 5, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Myocardial Ischemia

Coronary Artery Disease

Study Results

No Results Posted as of Jan 5, 2023