Actively Recruiting

Age: 21Years +
All Genders
ID05672706

A Study of Pressure Waveform Analysis in Coronary Artery-II

Led by National Taiwan University Hospital Hsin-Chu Branch · Updated on 2023-01-05

30

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study focuses on people with angina to explore the use of intracoronary adenosine during tests that measure coronary flow reserve (CFR) and index of microcirculatory resistance (IMR). Researchers aim to understand how repeatable these measurements are when adenosine is given and to evaluate how coronary waveform signals relate to ischemia defined by fractional flow reserve (FFR) and CFR. The study also looks at how well FFR, CFR, and IMR predict major cardiovascular problems over three years. Participants will undergo repeated intracoronary adenosine administration while CFR and IMR measurements are taken in a catheterization lab. This procedure helps assess heart blood flow and resistance in small vessels. The study involves monitoring these measurements during the procedure, followed by clinical follow-up over three years to track cardiovascular outcomes. During the study, participants will have FFR, CFR, and IMR assessments in the catheterization laboratory. The main outcome measured is the repeatability of CFR and IMR values within 10 minutes. Researchers will also follow participants for three years to observe major adverse cardiovascular events. This approach helps understand the reliability of the tests and their ability to predict future heart problems.

CONDITIONS

Brief Title

A Study of Pressure Waveform Analysis in Coronary Artery-II

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with angina
  • Age 21 years or older
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 10 minutes

Participants undergo repeat intracoronary adenosine administration during CFR and IMR measurement to assess coronary artery function.

1 visit (in-person)

Long-term Monitoring

Duration - 3 years

Participants are monitored for major adverse cardiovascular outcomes over a period of 3 years.

Periodic follow-up visits as determined by the study team

Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital Hsin-Chu branch

Hsinchu, Taiwan, 300

Actively Recruiting

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Research Team

C

Chien-Boon Jong, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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