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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00850473
Other study ID # 07-0813
Secondary ID 593F
Status Terminated
Phase N/A
First received
Last updated
Start date October 2007
Est. completion date September 2009

Study information

Verified date August 2018
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years oof age or older

- referred for cardiac catheterization.

- coronary artery disease that does not need angioplasty.

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.

Study Design


Intervention

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

Locations

Country Name City State
United States Cardiovascular Imaging Laboratory Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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