NCT00841932

Brief Summary

The purpose of this study is to assess the safety of performing fractional flow reserve (FFR) of the myocardium without using anticoagulation by performing a retrospective review of 100 consecutive patients who have undergone this procedure during diagnostic catheterization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Shorter than P25 for all trials

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

August 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

2 months

First QC Date

February 6, 2009

Last Update Submit

February 11, 2009

Conditions

Coronary Artery Disease

Keywords

Fractional Flow ReserveWithout anticoagulation

Outcome Measures

Primary Outcomes (1)

  • Complications related to use of pressure wire

    0-30 days (index procedure)

Secondary Outcomes (1)

  • Complications due to FFR procedure

    0-30 days (index hospitalization)

Study Arms (1)

Fractional Flow Reserve

Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis

Procedure: Fractional Flow Reserve

Interventions

Fractional Flow ReservePROCEDURE

Fractional Flow Reserve performed without anticoagulation

Fractional Flow Reserve

Eligibility Criteria

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

Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.

You may qualify if:

  • Patients with moderate stenosis who underwent FFR without anticoagulation

You may not qualify if:

  • Therapeutic anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Coronary CirculationBlood CirculationCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Jonathan Roberts, MD

    Clinyx, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 12, 2009

Study Start

August 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02