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NCT Number: NCT05672706

A Study of Pressure Waveform Analysis in Coronary Artery-II

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.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital Hsin-Chu branch

Hsinchu, 300, Taiwan

Location status: Recruiting

Location contact

Chien-Boon Jong, MD

CONTACT

[email protected]

035322140

Chien-Boon Jong, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CFR and IMR group

Procedure

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

Primary outcomes

  1. Repeatability of CFR and IMR value

    Time frame: 10 minutes

    To compare the difference of individual value, while repeat the measurement within 1 minutes

Secondary outcomes

  1. Major adverse cardiovascular outcomes

    Time frame: 3 year

    Including death, myocardial infarction, stroke and heart failure

Study contacts

Contact information is provided by the study sponsor or research team.

Chien-Boon Jong, MD

CONTACT

[email protected]

035322140 ext. 2010

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jan 5, 2023
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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