NCT05672706

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2023Dec 2027

First Submitted

Initial submission to the registry

January 3, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

January 3, 2023

Last Update Submit

January 3, 2023

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Repeatability of CFR and IMR value

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

    10 minutes

Secondary Outcomes (1)

  • Major adverse cardiovascular outcomes

    3 year

Study Arms (1)

CFR and IMR group

Procedure: CFR and IMR group

Interventions

CFR and IMR groupPROCEDURE

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

CFR and IMR group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with angina and undergo invasive coronary angiography

You may qualify if:

  • Participants with angina

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsin-Chu branch

Hsinchu, 300, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

4ml serum was collected at the end of the FFR procedure.

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Chien-Boon Jong, MD

CONTACT

035322140jgboon0407@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

January 4, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

January 5, 2023

Record last verified: 2023-01

Locations

TW(1)