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Magnetic Resonance Imaging of the Blood Vessels of the Heart

Primary Purpose

Heart Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Heart Disease focused on measuring Echocardiography, Heart, Gadolinium, Dobutamine, Toxicity, Adverse Events, Myocardial Infarction, Myocardial Viability, Myocardial Perfusion, Myocardial Function, Cardiovascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Inclusion Criteria for All Arms of the Protocol Known or suspected cardiovascular disease. 18 years of age and older. 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: 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: 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).

Sites / Locations

  • Suburban Hospital
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
August 2, 2022
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001638
Brief Title
Magnetic Resonance Imaging of the Blood Vessels of the Heart
Official Title
Cardiovascular Magnetic Resonance Imaging
Study Type
Observational

2. Study Status

Record Verification Date
August 4, 2009
Overall Recruitment Status
Completed
Study Start Date
September 29, 1997 (undefined)
Primary Completion Date
August 3, 2009 (Actual)
Study Completion Date
August 3, 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

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....
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
Echocardiography, Heart, Gadolinium, Dobutamine, Toxicity, Adverse Events, Myocardial Infarction, Myocardial Viability, Myocardial Perfusion, Myocardial Function, Cardiovascular Disease

7. Study Design

Enrollment
2916 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Inclusion Criteria for All Arms of the Protocol Known or suspected cardiovascular disease. 18 years of age and older. 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: 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: 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).
Facility Information:
Facility Name
Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7928216
Citation
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.
Results Reference
background
PubMed Identifier
7862963
Citation
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.
Results Reference
background
PubMed Identifier
1889423
Citation
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.
Results Reference
background

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Magnetic Resonance Imaging of the Blood Vessels of the Heart

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