- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00075920
Technical Development of Strain Rate Echocardiography
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.
연구 개요
상태
정황
상세 설명
연구 유형
등록
연락처 및 위치
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- 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.
공부 계획
연구는 어떻게 설계됩니까?
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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