NCT00850473

Brief Summary

This study is being done to determine if a picture taking test of the heart, positron emission tomography/computed tomography (or cardiac PET/CT), can identify the blockages in the heart arteries that lead to heart attacks when compared to the standard of heart catheterization.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
9 years until next milestone

Results Posted

Study results publicly available

August 29, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

February 20, 2009

Results QC Date

February 6, 2018

Last Update Submit

August 23, 2018

Conditions

Myocardial InfarctionCoronary Artery DiseaseCardiac Catheterization

Keywords

PETCTHeart AttackCoronary Artery diseaseCardiac Catheterization

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clear Anatomical Landmarks Confirmed by CT

    Coronary FDG uptake will be measured at the site of coronary stenosis. The target coronary stenosis will be identified by its proximity to a clear anatomical landmark seen on CT and conventional angiography.

    During PET CT scan, an average of 2 hours

Study Arms (1)

Positron Emitting Image

EXPERIMENTAL

Patient will have a PET/CT imaging study to determine cardiac stenosis, F-18 FDG and heparin/intralipid infusion and Contrast Dye.will be administered.

Diagnostic Test: PET/CT

Interventions

PET/CTDIAGNOSTIC_TEST

Patient will have one imaging modality - a Positron Emitting Tomography CT which includes F-18 FDG and heparin/intralipid infusion and Contrast Dye.

Also known as: PET/positron Emission Tomography imaging
Positron Emitting Image

Eligibility Criteria

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

You may qualify if:

  • years oof age or older
  • referred for cardiac catheterization.
  • coronary artery disease that does not need angioplasty.

You may not qualify if:

  • history of cardiac stents
  • bypass surgery
  • bad kidney function
  • unable to take beta blocker medication
  • history of asthma
  • allergies to egg containing products
  • atrial fibrillation
  • pregnancy
  • breastfeeding
  • overweight by definition of a BMI over 35.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Imaging Laboratory

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery Disease

Interventions

Positron Emission Tomography Computed TomographyPositron-Emission Tomography

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Limitations and Caveats

There were no limitations or caveats

Results Point of Contact

Title
Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
Organization
Washington University School of Medicine
groplerr@mir.wustl.edu
314-747-3877

Study Officials

  • Peter Rao, MD

    Washington University in St. Louis Physicians

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 25, 2009

Study Start

October 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 29, 2018

Results First Posted

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

there is no plan to make individual participant data available to other researchers

Locations

US(1)