Echocardiography, Doppler Clinical Trial
Official title:
Technical Development of Strain Rate Echocardiography
Verified date | October 17, 2007 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will examine heart function using two imaging techniques - echocardiography
(ultrasound) and magnetic resonance imaging (MRI) - to evaluate newly developed software for
echocardiograph machines. MRI and ultrasound both provide images of the heart structure and
function. MRI uses a magnetic field and radio waves to obtain the pictures, while
echocardiography uses sound waves.
Patients with any form of heart disease and healthy volunteers 21 years of age and older may
be eligible for this study. Candidates must be and able to undergo magnetic resonance imaging
and must not have an irregular heart rhythm, heart valve disease, a pacemaker, defibrillator
implant, insulin pump, or other metallic implant.
Participants will have two ultrasound examinations and two magnetic resonance imaging
examinations, as described below. All the tests will be completed within 24 to 48 hours.
Echocardiography :
For this test, a small probe is passed over the chest. Sound waves emitted from the probe
bounce off the heart and are beamed back into the echo machine where they are recorded. The
sonographer does a baseline test, which is evaluated by the physician. Then, after a 10- to
20-minute break, portions of the test are repeated. The entire exam takes about 2 hours.
Magnetic Resonance Imaging:
For MRI, the subject lies on a table that slides into a long doughnut-shaped scanner. A small
tube is placed in a vein in the hand or arm to give fluids and to infuse gadolinium, a
contrast material that brightens the images. Heart rate and blood pressure are monitored
during the study, which takes about 3 hours.
Status | Completed |
Enrollment | 125 |
Est. completion date | October 17, 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: Adults older than 18 years will be recruited for the CAD group. Since regional wall motion abnormalities, coronary artery disease, and heart failure are rare in subjects under 21, we will limit this group to adults only. Adults older than age 18 who have undergone surgical repair of Tetralogy of Fallot will be recruited. Normal controls will be age-matched to this group of patients. Able to provide written informed consent. EXCLUSION CRITERIA: Patients with pulmonary artery shunts placed within the last 6 months are not eligible to undergo MRI scanning. Pregnant or lactating (patients with uncertain pregnancy status will be required to have a screening urine or blood pregnancy test). Chronic atrial fibrillation; frequent PVC's (more than 1 every 10 heart beats). Cardiac pacemaker, defibrillator, or other metallic implant which would exclude subject from MRI examination (examples: central nervous system aneurysm clips, implanted neural stimulator, cochlear implant, ocular foreign body, insulin pump, metal shrapnel or bullet). Inability to provide written informed consent. Patients with hemoglobinopathies or renal disease with a creatinine clearance (CrCl) less than 20 ml/min will be excluded from MRI sequences involving administration of MRI contrast agents. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Katz WE, Gulati VK, Mahler CM, Gorcsan J 3rd. Quantitative evaluation of the segmental left ventricular response to dobutamine stress by tissue Doppler echocardiography. Am J Cardiol. 1997 Apr 15;79(8):1036-42. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03088943 -
Intraoperative Diastolic Function by TDI and STE
|
N/A |