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TerminatedNCT00850473PET/CTUpdated Aug 29, 2018Results posted

PET/CT Study in the Diagnosis of Coronary Plaque

An interventional study of PET/CT in Myocardial Infarction, Coronary Artery Disease and Cardiac Catheterization, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Sub-investigator left the university
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Heart catheterization, in which a thin plastic tube, or catheter, is placed into an artery in the arm or leg and advanced into the heart arteries, is the procedure that you and your doctor have decided to pursue to look for heart artery blockages. It is being performed as part of your standard care and not for research purposes. The research procedure (cardiac PET/CT), which will be performed at a later date is a combination of heart CT (a test that involves the use of x-rays to identify heart artery blockages) and heart PET (an imaging test that uses a radioactive drug to look at how the heart uses fuel (sugar and fats) These tests will be combined (PET/CT) to look for the presence and type of blockage in your heart arteries.

It is important to develop a test that can determine if and what type of blockage you have in your heart arteries as the presence and type of heart artery blockage is a very important predictor of heart attack and death from heart attack.

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Conditions studied

  • Myocardial Infarction
  • Coronary Artery Disease
  • Cardiac Catheterization

Keywords

  • PET
  • CT
  • Heart Attack
  • Coronary Artery disease
  • Cardiac Catheterization
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 3 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Positron Emitting Image

    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

  • Diagnostic testPET/CT

    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

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What researchers measure

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.

    Time frame: During PET CT scan, an average of 2 hours

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Results

Posted Aug 29, 2018
Limitations and caveats
There were no limitations or caveats

Participant flow

Participant flow — Overall Study
MilestonePositron Emitting Image, F-18 FDG, Contrast Dye
Started3
Completed3
Not completed0

Outcome measures

PrimaryNumber 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.

Time frame:
During PET CT scan, an average of 2 hours
Reported as:
Count of participants · Participants
Number of Participants With Clear Anatomical Landmarks Confirmed by CT
ParticipantsPositron Emitting Image
Number of Participants With Clear Anatomical Landmarks Confirmed by CT3

Adverse events

Collected over During PET CT scan an average of 2 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Positron Emitting Image, F18 FDG, Contrast Dye0/3 (0%)0/3 (0%)0/3 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Positron Emitting Image, F18 FDG, Contrast Dye
<=18 years0
Between 18 and 65 years3
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Positron Emitting Image, F18 FDG, Contrast Dye
Female2
Male1
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Positron Emitting Image, F18 FDG, Contrast Dye
Region of Enrollment
Region of Enrollment(Participants)Positron Emitting Image, F18 FDG, Contrast Dye
United States3
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Study locations

1 site
  • Cardiovascular Imaging Laboratory
    Saint Louis, Missouri 63110, United States
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References and documents

Individual participant data

Plan to share: No — there is no plan to make individual participant data available to other researchers

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00850473
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Feb 25, 2009
Start date
Oct 2007
Primary completion
Sep 2009
Completion
Sep 2009
Results posted
Aug 29, 2018
Last update
Aug 29, 2018

Study contacts

Peter Rao, MD
principal investigator · Washington University in St. Louis Physicians

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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