Completed

Real Time 3-Dimensional Stress Echocardiography

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What is being tested

Real time 3-dimensional stress echocardiography

Procedure
Who is being recruted

Arterial Occlusive Diseases+8

+ Arteriosclerosis

+ Cardiovascular Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 1999
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1999

Actual date on which the first participant was enrolled.

Stress echocardiography has become a valuable technique for the non-invasive detection of coronary artery disease. Its accuracy has been shown to be superior to that of the exercise electrocardiogram and comparable to that of myocardial perfusion imaging. The adequacy of stress echocardiography with conventional two-dimensional imaging, however, is highly dependent on operator expertise. Further, interpretation of test results is subjective and qualitative, and is based on analysis of wall motion after arbitrary segmentation of the left ventricle. Real time 3-dimensional (RT3D) echocardiography is a new technique that permits the unrestricted assessment of left ventricular wall motion and function in a single cardiac beat without ECG or respiratory gating. We hypothesize that RT3D echocardiography will have similar or greater accuracy for the detection of wall motion abnormalities compared to the conventional two-dimensional examination. We therefore propose to acquire RT3D echocardiographic images in patients with known or suspected coronary artery disease who undergo stress echocardiography. We will correlate these results with findings from coronary angiography and compare the ability of RT3D echocardiography to detect coronary artery disease with that of the conventional two-dimensional exam.

NCT00001886
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaCoronary Artery DiseaseCoronary DiseaseIschemia

Criteria

Patients older than 18 years of age with known or suspected coronary artery disease who agree to undergo stress echocardiography and have undergone or will undergo coronary angiography within 3 months of the stress echocardiogram. No pre-menopausal patients who are lactating, are pregnant or potentially pregnant as judged by history, physical examination, ultrasound or urine pregnancy test. No unstable angina. No recent myocardial infarction (less than 1 month). No ventricular ectopy during baseline conditions (i.e., couplets, frequent PVC's [greater than 6/min], early coupling ["R-on-T" phenomenon], ventricular bigeminy) that might potentially predispose the patient for the development of dangerous dysrhythmias during dobutamine infusion. No congestive heart failure. No significant hypertension (systolic blood pressure greater than 170 mmHg) or hypotension (systolic blood pressure less than 100 mmHg). No sinus tachycardia greater than 100 beats/min. No other acute medical illness. No atrial fibrillation, or inadequate two-dimensional echocardiographic windows.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps
CompletedOne Study Center