NCT03117218

Brief Summary

This study aims to evaluate whether quantitative analysis of coronary MR angiogram would improve the detection of functionally-significant coronary artery stenosis.

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
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

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

July 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

April 12, 2017

Last Update Submit

April 16, 2017

Conditions

Coronary Artery DiseaseMagnetic Resonance AngiographyFractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

  • Presence of functionally significant coronary stenosis

    fractional flow reserve \< 0.8

    within 1 month

Interventions

Coronary MR angiographyDIAGNOSTIC_TEST

Quantitative analysis of coronary MR angiogram

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary stenosis on coronary MR angiograms who were planned to undergo invasive coronary angiography.

You may qualify if:

  • Age ≥ 18 years
  • or more coronary stenoses in the major coronary artery with a vessel diameter ≥ 2mm on coronary MR angiogram
  • Patient who were planned to undergo invasive coronary angiography and fractional flow reserve

You may not qualify if:

  • clinically unstable patient
  • a history of coronary revascularization
  • infiltrative cardiomyopathy, hypertropic cardiomyopathy, myocarditis
  • contraindication to use of adenosine
  • complete occlusion of target lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hopsital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Yeonyee E Yoon, MD

CONTACT

+82-31-787-7072yeonyeeyoon@snubh.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 17, 2017

Study Start

July 1, 2014

Primary Completion

December 31, 2017

Study Completion

May 31, 2018

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)