Prognostic Value of High Dose Dobutamine Stress Magnetic Resonance Imaging
Information source: Heidelberg University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease (CAD)
Phase: N/A
Status: Completed
Sponsored by: Heidelberg University
Summary
High-dose dobutamine/atropine stress cardiac magnetic resonance imaging (DS-MRI) has been
incorporated in daily clinical practice for the detection of ischemic heart disease.
Thus, wall motion abnormalities (WMA) during stress, precede the development of ST-segment
depression on ECG and of anginal symptoms and aid in the detection of anatomically
significant coronary artery disease (CAD).
DS-MRI offers the possibility to integrate myocardial perfusion and wall motion analysis in
a single examination. In this regard, recent data suggest that the assessment of myocardial
wall motion and perfusion during a single session may enhance the sensitivity of the
technique for the diagnosis of CAD.
However, to date limited data is available on the prognostic value of high-dose DS-MRI in
large patient cohorts, treated according to current guidelines.
Assessment of long-term outcome of DS-MRI is important because this test may identify both
high-risk patients, who would benefit from invasive diagnostic and therapy, and lower-risk
patients in whom additional procedures and intensive medical follow-up are not required.
In the present study we aim to determine the value of wall motion and perfusion assessment
during high-dose dobutamine/atropine MRI in predicting cardiac events.
In addition, the incremental value of the MR-stress testing results was assessed (inducible
wall motion, perfusion abnormalities and the combination of both) after the consideration of
traditional clinical risk factors and baseline ejection fraction.
Clinical Details
Official title: Prognostic Value of High Dose Dobutamine Stress Magnetic Resonance in Patients With Ischemic Heart Disease. Assessment of Myocardial Perfusion and Wall Motion.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Cardiac death and nonfatal myocardial infarction (MACEs)
Secondary outcome: Late revascularization (90 days after the MR-examination)
Detailed description:
Background: High-dose dobutamine stress cardiac magnetic resonance imaging (DS-MRI) is
incorporated in daily clinical practice for the detection of coronary artery disease (CAD).
Purpose: To determine the value of wall motion and perfusion assessment during DS-MRI for
the prediction of cardiac events in a large patient cohort.
Methods:
Cardiovascular MR-Examination. Patients are examined in a clinical 1. 5-T whole-body
MR-scanner Achieva system (Philips Medical Systems, Best, The Netherlands) using a 5-element
cardiac phased-array receiver coil. Cardiovascular MR-images were acquired at rest and
during a standardized high-dose dobutamine/atropine protocol involving short breath holds,
and using a vector electrocardiogram for R-wave triggering11. Electrocardiographic rhythm
and symptoms were monitored continuously, and blood pressure was measured every 3 minutes.
Follow-up Data. Personnel unaware of the stress testing results contacts each subject or an
immediate family member and the date of this contact was used for calculating the follow-up
time duration. Outcome data iscollected from a standardized questionnaire and determined
from patient interviews at the outpatient clinic or by telephone interviews. Reported
clinical events are confirmed by review of the corresponding medical records in our
electronic Hospital Information System (HIS), contact with the general practitioner,
referring cardiologist or the treating hospital. Cardiac death and nonfatal myocardial
infarction are registered as major cardiac events. Cardiac death is defined as death from
any cardiac cause (lethal arrhythmia, myocardial infarction, or congestive heart failure) or
sudden unexpected death occurring without another explanation. Myocardial infarction is
defined by angina of >30 minutes duration and either ST segment elevation of ≥2mm in 2
consecutive ECG leads or a rise in troponin T of ≥0. 03µg/l.
Other events include clinically indicated coronary arterial revascularization by
percutaneous coronary angioplasty (PCI) or coronary artery bypass graft (CABG).
In case of 2 simultaneous cardiac events, the worst event was selected (cardiac
death>non-fatal myocardial infarction>revascularization).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Written informed consent before the MR-examination
Exclusion Criteria:
- Non-sinus rhythm, unstable angina, severe arterial hypertension (>200/120 mmHg),
moderate or severe valvular disease and general contraindications to MRI (implanted
pacemakers or defibrillators, intracranial metal)
Locations and Contacts
University of Heidelberg, Department of Cardiology, Heidelberg 69120, Germany
Additional Information
Starting date: January 2005
Last updated: March 28, 2012
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