NCT00001631

Brief Summary

Blood flows to areas of the heart providing oxygen and fuel to the pumping muscle. Occasionally the arteries providing the fuel can become blocked. This occurs in coronary artery disease. Magnetic resonance imaging (MRI) can be used to evaluate the blood flow to different areas of the heart muscle. In this study magnetic resonance imaging will be compared to other diagnostic tests (radionucleotide perfusion studies) capable of measuring blood flow to heart muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 1997

Longer than P75 for phase_2

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

August 1, 1997

Completed
2.3 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
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Coronary DiseaseHealthyHypertrophic CardiomyopathyMyocardial Ischemia

Keywords

GadoliniumIschemiaCoronary Artery DiseaseHypertrophic CardiomyopathyDipyridamole

Interventions

Magnetic resonance imagingPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 to 80.
  • Either sex.
  • Capable of giving informed consent.
  • Group 1: Outpatients with known or suspected coronary artery disease with clinical indication for radionuclide perfusion imaging.
  • Group 2: Patients with non-obstructive hypertrophic cardiomyopathy with clinical indication for radionuclide perfusion imaging.
  • Group 3: Normal volunteers.
  • Positive stress thallium or stress sestamibi (i.e., exercise, adenosine, dobutamine or dypiridamole) at the NIH.

You may not qualify if:

  • Pregnancy.
  • Unstable angina.
  • Uncontrolled hypertension (SBP greater than 185, DBP greater than 105).
  • Recent myocardial infarction (less than 5 days).
  • nd or 3rd degree heart block by ECG.
  • Asthma, emphysema, renal failure, acute medical illness (fever, pneumonia, etc.) or anemia (hct less than 30).
  • Cardiac pacemaker or implantable defibrillator, aneurysm clip, neural stimulator, any type of ear implant, metal in your eye, any implanted device (i.e. insulin pump, drug infusion device) or any metallic foreign body, shrapnel, or bullet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Wilke N, Simm C, Zhang J, Ellermann J, Ya X, Merkle H, Path G, Ludemann H, Bache RJ, Ugurbil K. Contrast-enhanced first pass myocardial perfusion imaging: correlation between myocardial blood flow in dogs at rest and during hyperemia. Magn Reson Med. 1993 Apr;29(4):485-97. doi: 10.1002/mrm.1910290410.

    PMID: 8464365BACKGROUND

  • Matheijssen NA, Louwerenburg HW, van Rugge FP, Arens RP, Kauer B, de Roos A, van der Wall EE. Comparison of ultrafast dipyridamole magnetic resonance imaging with dipyridamole SestaMIBI SPECT for detection of perfusion abnormalities in patients with one-vessel coronary artery disease: assessment by quantitative model fitting. Magn Reson Med. 1996 Feb;35(2):221-8. doi: 10.1002/mrm.1910350214.

    PMID: 8622587BACKGROUND

  • Zaman M, Hashmi R, Niaz K, Ahmad A, Kamal S. Safety of pharmacological (intravenous dipyridamole) stress for Thallium-201 perfusion imaging in patients with coronary artery disease unable to exercise. J Pak Med Assoc. 1994 Oct;44(10):237-9.

    PMID: 7815687BACKGROUND

MeSH Terms

Conditions

Coronary DiseaseCardiomyopathy, HypertrophicMyocardial IschemiaIschemiaCoronary Artery Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCardiomyopathiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1997

Study Completion

January 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-01

Locations

US(1)