NCT01681524

Brief Summary

The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3 coronary-artery-disease

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 28, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 30, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

August 28, 2012

Last Update Submit

May 29, 2013

Conditions

Coronary Artery Disease

Keywords

Flurpiridaz F18 InjectionPositron Emission Tomography Myocardial Perfusion ImagingSingle Positron Emission Computed TomographyCoronary Artery DiseaseMyocardia IschemiaCoronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography

    12 months

Secondary Outcomes (7)

  • Diagnostic performance evaluation of CAD (PETVsSPECT)

    12 months

  • Diagnositic performance evaluation of multivessel disease (PETvsSPECT)

    12 months

  • Detection of CAD in subgroups: pharm stress, females and BMI>/=30

    12 months

  • Image quality of rest and stress (PETvsSPECT)

    12 months

  • Diagnostic certainty evaluation of rest and stress (PETvsSPECT)

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Flurpiridaz F18

EXPERIMENTAL

Open-label study of a single injection of flurpiridaz F18 for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization

Drug: Flurpiridaz F18

Interventions

Flurpiridaz F18DRUG

Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Flurpiridaz F18

Eligibility Criteria

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

You may qualify if:

  • Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details

You may not qualify if:

  • Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control Unstable cardiac status History of coronary artery bypass graft History of PCI within the past six months See protocol for additional details

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Interventions

BMS 747158-02

Condition Hierarchy (Ancestors)

Myocardial Ischemia

Study Officials

  • Cesare Orlandi, MD

    Lantheus Medical Imaging

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 10, 2012

Study Start

November 1, 2012

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

May 30, 2013

Record last verified: 2013-04