Cardiac Catheterization, Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
PET, CT, Heart Attack, Coronary Artery disease, Cardiac Catheterization
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.
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.
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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clear Anatomical Landmarks Confirmed by CT | During PET CT scan, an average of 2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Positron Emitting Image, F18 FDG, Contrast Dye Patient will have a PET/CT imaging study to determine cardiac stenosis, patient will have an injection of F18 FDG to determine the metabolic uptake of the radio-isotope, patient will have contrast dye injected to better visualize the coronary arteries. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Positron Emitting Image, F18 FDG, Contrast Dye | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 3 Participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: During PET CT scan, an average of 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positron Emitting Image | Number of Participants With Clear Anatomical Landmarks Confirmed by CT | 3 Participants |