NCT01478100

Brief Summary

The investigators examined the feasibility of treatment planning using virtual coronary revascularization and fractional flow reserve (FFR) CT before the invasive procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

1 month

First QC Date

November 20, 2011

Last Update Submit

November 22, 2011

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseCTComputational flow dynamics

Eligibility Criteria

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

From the DISCOVER-FLOW study 20 patients with available post-intervention FFR were included in this study.

You may qualify if:

  • Significant stenosis at CT angiography
  • Normal ejection fraction on echocardiography
  • Informed consented patient

You may not qualify if:

  • Total occlusion and collateral flow to target vessel
  • AV conduction abnormality
  • Left ventricular hypertrophy
  • Significant valvular heart or primary myocardial disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim KH, Doh JH, Koo BK, Min JK, Erglis A, Yang HM, Park KW, Lee HY, Kang HJ, Kim YJ, Lee SY, Kim HS. A novel noninvasive technology for treatment planning using virtual coronary stenting and computed tomography-derived computed fractional flow reserve. JACC Cardiovasc Interv. 2014 Jan;7(1):72-8. doi: 10.1016/j.jcin.2013.05.024. Epub 2013 Dec 11.

    PMID: 24332418DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

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

Study Record Dates

First Submitted

November 20, 2011

First Posted

November 23, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

KR(1)