A Study of Pressure Waveform Analysis in Coronary Artery-II

January 3, 2023 updated by: National Taiwan University Hospital Hsin-Chu Branch

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with angina and undergo invasive coronary angiography

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatability of CFR and IMR value
Time Frame: 10 minutes
To compare the difference of individual value, while repeat the measurement within 1 minutes
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular outcomes
Time Frame: 3 year
Including death, myocardial infarction, stroke and heart failure
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 4, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111-129-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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