NCT04401657

Brief Summary

This is a prospective, single center study involving 150 patients with stable coronary artery disease undergoing coronary angiography for chest pain evaluation. The relationship between FFR values and inducible myocardial ischemia at the time of definite ischemia during adenosine stress testing will be investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 8, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

May 19, 2020

Last Update Submit

July 19, 2021

Conditions

Coronary Artery Stenosis

Keywords

Coronary artery diseaseMyocardial ischemiaFractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • Definite myocardial ischemia

    Echocardiographic wall motion score index score by 17-segment model or ST segment elevation/depression by 12-lead ECG during adenosine stress testing

    during adenosine stress testing

Study Arms (1)

FFR Measurement

EXPERIMENTAL

Myocardia ischemia evaluation during adenosine stress testing

Diagnostic Test: Fractional flow reserve with adenosine stress testing

Interventions

Fractional flow reserve with adenosine stress testingDIAGNOSTIC_TEST

ECG, FFR, and two-dimensional echocardiographic monitoring will be continued before, during and after adenosine infusion.

FFR Measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women at least 18 years of age
  • Patients undergoing coronary angiography
  • Moderate to severe stenosis (diameter stenosis equal or more than 50 percent by visual examination) in one major epicardial coronary artery
  • Normal left ventricular function without regional wall motion abnormality

You may not qualify if:

  • Contraindications to adenosine stress test\*
  • ECG abnormalities (bundle branch block, LVH with strain, pacing rhythm, WPW)
  • History of previous myocardial infarction
  • Significant multi-vessel coronary artery disease (diameter stenosis equal or more than 50%)
  • Hypertrophic cardiomyopathy
  • Significant valvular heart disease
  • Bronchial asthma or chronic obstructive lung disease
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
  • Current treatment for the active cancer
  • Expected life expectancy \< 1 year
  • Unwillingness or inability to comply with the procedures described in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary StenosisCoronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Cheol Whan Lee, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Do-Yoon Kang, MD

CONTACT

82-2-3010-1745kdy1218@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 26, 2020

Study Start

May 8, 2020

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)