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CompletedNCT00001638Updated Aug 4, 2022

Magnetic Resonance Imaging of the Blood Vessels of the Heart

An observational study in Heart Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Enrollment
2,916
Ages
18 Years and older
Sex
All
01

Study 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....

Read the detailed description

This is a teaching protocol. It is in a format for training physicians in the laboratory in cardiovascular MRI techniques necessary for our research protocols. It helps provide experience necessary to develop and maintain our clinical expertise with cardiovascular MRI methods. It also provides physicians in the region access to this technology.

02

Conditions studied

  • Heart Disease

Keywords

  • Echocardiography
  • Heart
  • Gadolinium
  • Dobutamine
  • Toxicity
  • Adverse Events
  • Myocardial Infarction
  • Myocardial Viability
  • Myocardial Perfusion
  • Myocardial Function
  • Cardiovascular Disease
03

In context

Heart Diseases

3,674 studies on the registry are indexed under Heart Diseases; 458 are open to participants now.

This study's enrollment of 2,916 is above the median of 295 across 1,250 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 72 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 50 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • INCLUSION CRITERIA:

Inclusion Criteria for All Arms of the Protocol

  1. Known or suspected cardiovascular disease.
  2. 18 years of age and older.
  3. Able to provide informed consent.

Exclusion Criteria for All Arms of the Protocol:

Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:

  1. Central nervous system aneurysm clips
  2. Implanted neural stimulator
  3. Implanted cardiac pacemaker or defibrillator
  4. Cochlear implant
  5. Ocular foreign body (e.g. metal shavings)
  6. Implanted insulin pump
  7. Metal shrapnel or bullet.

In addition the following patient groups will be excluded:

  1. Pregnant women (Patients who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test)
  2. 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:

  1. lactating women unless they are willing to discard breast milk for 24 hours
  2. 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:

eGFR (ml/min/l.73 m(2))= 175 x (serum creatinine)-l.l54 x (age)-0.203 x 0.742 (if the subject is female) x 1.212 (if the subject is black)

Additional Exclusion Criteria for Dobutamine MRI

  1. Myocardial infarction within 48 hours.
  2. Uncontrolled heart failure
  3. Severe hypertension (SBP greater than 200, DBP greater than 110)
  4. Atrial fibrillation
  5. Ventricular tachycardia
  6. Frequent PVC's (more than 1 every 10 heart beats or nonsustained ventricular tachycardia (greater than 4)
  7. Patients with narrow angle glaucoma or known or suspected severe bladder outlet obstruction due to prostatic hypertrophy will not receive atropine

Additional Exclusion Criteria for Vasodilator Stress MRI

  1. Myocardial infarction within 48 hours.
  2. Patients that are not considered medically stable by their physician (for example, severe heart failure that makes it difficult to breathe while lying flat or severe problems with heart rhythms).
  3. Patients with 2nd or 3rd degree heart block are excluded from receiving the medicine adenosine (abnormalities that can be seen on your ECG).
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Study design

Enrollment
2,916 participants (actual)
06

Study locations

2 sites
  • Suburban Hospital
    Bethesda, Maryland 20814, United States
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. PubMed 7928216 ↗
  • 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. PubMed 7862963 ↗
  • 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. PubMed 1889423 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 1997, a primary completion of Aug 2009 and a completion of Aug 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Nov 4, 1999
Start
Sep 29, 1997
Primary completionActual
Aug 3, 2009
CompletionActual
Aug 3, 2009
Last update
Aug 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00001638
First posted
Nov 4, 1999
Start date
Sep 29, 1997
Primary completion
Aug 3, 2009
Completion
Aug 3, 2009
Last update
Aug 4, 2022
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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