A Study of Pressure Waveform Analysis in Coronary Artery-II

NCT ID: NCT05672706

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-04

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CFR and IMR group

CFR and IMR group

Intervention Type PROCEDURE

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

Interventions

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CFR and IMR group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital Hsin-Chu branch

Hsinchu, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chien-Boon Jong, MD

Role: CONTACT

035322140 ext. 2010

Facility Contacts

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Chien-Boon Jong, MD

Role: primary

035322140

Other Identifiers

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111-129-E

Identifier Type: -

Identifier Source: org_study_id

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