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Heart DiseaseNCT00001638

Magnetic Resonance Imaging of the Blood Vessels of the Heart

An observational study of Heart Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Disease
How many people
2,916 participants
Where
2 sitesUnited States
Study dates
29 Sep 1997to 3 Aug 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 28Show fewer
  • 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:
  • 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
  • Myocardial infarction within 48 hours.
  • Uncontrolled heart failure
  • Severe hypertension (SBP greater than 200, DBP greater than 110)
  • Atrial fibrillation
  • Ventricular tachycardia
  • Frequent PVC's (more than 1 every 10 heart beats or nonsustained ventricular tachycardia (greater than 4)
  • 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
  • Myocardial infarction within 48 hours.
  • 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).
  • Patients with 2nd or 3rd degree heart block are excluded from receiving the medicine adenosine (abnormalities that can be seen on your ECG).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Cardiovascular Magnetic Resonance Imaging

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.

Conditions
Heart Disease
Keywords
Echocardiography, Heart, Gadolinium, Dobutamine, Toxicity, Adverse Events, Myocardial Infarction, Myocardial Viability, Myocardial Perfusion, Myocardial Function, Cardiovascular Disease
Medical subject headings
Heart Diseases, Myocardial Infarction, Cardiovascular Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 1999 (estimated)
  2. Study start29 Sep 1997
  3. Primary completion3 Aug 2009
  4. Study completion3 Aug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
2,916 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001638
Sponsor's protocol ID
970204
Other IDs
97-H-0204
Status last verified
4 Aug 2009
First submitted
3 Nov 1999
Last updated
4 Aug 2022
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001638, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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