Ignite Creation Date:
2024-05-05 @ 9:11 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00837005
Status:
COMPLETED
Last Update Posted:
2012-04-02
First Post:
2009-02-03
Brief Title:
Prognostic Value of High Dose Dobutamine Stress Magnetic Resonance Imaging
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Prognostic Value of High Dose Dobutamine Stress Magnetic Resonance in Patients With Ischemic Heart Disease Assessment of Myocardial Perfusion and Wall Motion
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DS-Prognosis
Brief Summary:
High-dose dobutamineatropine 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 dobutamineatropine 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
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 dobutamineatropine 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
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 15-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 dobutamineatropine 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 003µgl
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 deathnon-fatal myocardial infarctionrevascularization
Methods
Cardiovascular MR-Examination Patients are examined in a clinical 15-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 dobutamineatropine 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 003µgl
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 deathnon-fatal myocardial infarctionrevascularization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None