NCT00075920

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2004

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2007

Completed
Last Updated

July 2, 2017

Status Verified

October 17, 2007

First QC Date

January 11, 2004

Last Update Submit

June 30, 2017

Conditions

Echocardiography, Doppler

Keywords

HeartFunctionUltrasoundMRILeft VentricleHealthy VolunteerHVHeart Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • 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. doi: 10.1016/s0002-9149(97)00043-x.

    PMID: 9114760BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 11, 2004

First Posted

January 12, 2004

Study Start

January 8, 2004

Study Completion

October 17, 2007

Last Updated

July 2, 2017

Record last verified: 2007-10-17

Locations

US(1)