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Recruiting NCT05672706

A Study of Pressure Waveform Analysis in Coronary Artery-II

Observational Ischemic Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CFR and IMR group.
Who it may be relevant to
Registry conditions: Ischemic Heart Disease. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Repeatability of CFR and IMR value [Time frame: 10 minutes]
Secondary outcome measures (1)
  • Major adverse cardiovascular outcomes [Time frame: 3 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital Hsin-Chu branch — Hsinchu

Identifiers

NCT: NCT05672706 · 111-129-E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗