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A Study of Pressure Waveform Analysis in Coronary Artery-II

A Study of Pressure Waveform Analysis in Coronary Artery-II

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05672706
Enrollment
30
Registered
2023-01-05
Start date
2023-01-04
Completion date
2027-12-31
Last updated
2023-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Brief summary

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

PROCEDURECFR and IMR group

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

Sponsors

National Taiwan University Hospital Hsin-Chu Branch
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Repeatability of CFR and IMR value10 minutesTo compare the difference of individual value, while repeat the measurement within 1 minutes

Secondary

MeasureTime frameDescription
Major adverse cardiovascular outcomes3 yearIncluding death, myocardial infarction, stroke and heart failure

Countries

Taiwan

Contacts

Primary ContactChien-Boon Jong, MD
jgboon0407@gmail.com035322140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026