NCT00001638

Brief Summary

This study is directed at evaluating patients with "myocardial ischemia" or poor blood supply to the heart muscle due to coronary artery disease. The major objective of this study is to determine the level of safety and effectiveness of magnetic resonance imaging at diagnosing coronary artery disease. In addition, this study will allow researchers at the National Institutes of Health to see a broad spectrum of disease, preserve clinical skills, and stimulate future ideas for clinical research....

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,916

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1997

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

September 29, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2009

Completed
Last Updated

August 4, 2022

Status Verified

August 4, 2009

Enrollment Period

11.9 years

First QC Date

November 3, 1999

Last Update Submit

August 2, 2022

Conditions

Heart Disease

Keywords

EchocardiographyHeartGadoliniumDobutamineToxicityAdverse EventsMyocardial InfarctionMyocardial ViabilityMyocardial PerfusionMyocardial FunctionCardiovascular Disease

Eligibility Criteria

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

You may qualify if:

  • Known or suspected cardiovascular disease.
  • years of age and older.
  • Able to provide informed consent.

You may not qualify if:

  • Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
  • Central nervous system aneurysm clips
  • Implanted neural stimulator
  • Implanted cardiac pacemaker or defibrillator
  • Cochlear implant
  • Ocular foreign body (e.g. metal shavings)
  • Implanted insulin pump
  • Metal shrapnel or bullet.
  • In addition the following patient groups will be excluded:
  • Pregnant women (Patients who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test)
  • Patients with symptoms of myocardial ischemia occurring despite maximally tolerated doses of oral antianginal therapy and intravenous nitroglycerin
  • Furthermore, the following patient groups will be excluded from studies involving the administration of MRI contrast agents:
  • lactating women unless they are willing to discard breast milk for 24 hours
  • renal disease (estimated glomerular filtration rate \[eGFR\] less than 30 ml/min/1.73 m(2) body surface area)
  • The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to patients with acute renal insufficiency:
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.

    PMID: 7928216BACKGROUND

  • Mattay VS, Weinberger DR, Barrios FA, Sobering GS, Kotrla KJ, van Gelderen P, Duyn JH, Sexton RH, Moonen CT, Frank JA. Brain mapping with functional MR imaging: comparison of gradient-echo--based exogenous and endogenous contrast techniques. Radiology. 1995 Mar;194(3):687-91. doi: 10.1148/radiology.194.3.7862963.

    PMID: 7862963BACKGROUND

  • Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.

    PMID: 1889423BACKGROUND

MeSH Terms

Conditions

Heart DiseasesMyocardial InfarctionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

September 29, 1997

Primary Completion

August 3, 2009

Study Completion

August 3, 2009

Last Updated

August 4, 2022

Record last verified: 2009-08-04

Locations

US(2)