Coronary Artery DiseaseNCT01568502
Dobutamine Stress Cardiac Magnetic Resonance Versus Echocardiography for the Assessment of Outcome. Are the Two Imaging Modalities Comparable?
An observational study of Coronary Artery Disease, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Dobutamine stress echocardiography (DSE) and cardiac magnetic resonance (DCMR) are both established non-invasive techniques, used in the clinical routine for the diagnostic classification and risk stratification of patients with suspected or known coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 5,008 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Jan 2012
- 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
Study population: Consecutive patients referred to our institution for clinically indicated dobutamine stress testing (either DSCMR or DSE) due to suspected or known CAD(with/without prior revascularization and with/without history of previous myocardial infarction).
Who may be able to join
- written informed consent before the DSE or DSCMR-examination
Who cannot join
- unstable angina
- severe arterial hypertension (>200/120mmHg)
- moderate or severe valvular disease
- general contraindications to dobutamine stress echocardiography:poor echogenic windows limiting endocardial border detection in ≥2 myocardial segments
- general contraindications to dobutamine stress cardiac magnetic resonance: implanted pacemakers or cardioverter defibrillator, claustrophobia
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Heidelberg, Department of Cardiology
Heidelberg, Baden-Wurttemberg, 69120
About this study
Dobutamine stress echocardiography (DSE) and cardiac magnetic resonance (DCMR) are both established non-invasive techniques, used in the clinical routine for the diagnostic classification and risk stratification of patients with suspected or known coronary artery disease (CAD).
In this regard, regional wall motion abnormalities (WMA) during dobutamine stress, precede the development of ST-segment depression and anginal symptoms, enabling the detection of anatomically significant CAD and the assessment of clinical outcomes.
Read more
In a head-to-head comparison between the 2 techniques, favourable diagnostic characteristics in terms of higher sensitivity and accuracy were noted for DCMR compared to DSE.
Although it has been reported that stress induced WMA both in DCMR and in DSE are independent predictors for hard cardiac events such as cardiac death or myocardial infarction, the value of the 2 techniques for the risk stratification of patients with CAD has not been compared to each other so far.
Comparison of these 2 non-invasive techniques is important, because referring physicians need to know which modality is more reliable for the identification of patients at higher risk for subsequent cardiac events, who would benefit from early invasive therapy.
In the investigators study the investigators therefore sought to compare the ability of DSE versus DCMR to predict subsequent hard cardiac events and revascularization procedures in a patient cohort with high CAD prevalence. Their predictive value was compared to that of conventional atherogenic risk factors and to resting WMA. In addition, the investigators sought to determine if both techniques are equally suitable for structuring invasive or conservative treatment according to the presence or absence of inducible ischemia, respectively.
Read the detailed description
Background: Both DSE and DCMR are implemented in the daily diagnostic work-up of patients with ischemic heart disease. Although DCMR was previously shown to aid the diagnostic classification of patients with suspected CAD with higher sensitivity and accuracy compared to that provided by DSE, the value of the 2 techniques for the risk stratification of patients with CAD has not been investigated so far.
Methods: Patients with suspected or known CAD underwent either DSE or DCMR for clinical reasons using the same standardised high-dose dobutamine/atropine protocol. Patient matching was performed for age, gender and coronary risk factors. Wall motion was assessed at rest and during maximum stress, and outcome data including cardiac death and non-fatal myocardial infarction (defined as hard cardiac events) and 'late' revascularization performed >90 days after the MR-scans were prospectively collected at least 6 months after DSE or DCMR.
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 is collected 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).
- Conditions
- Coronary Artery Disease
- Keywords
- dobutamine stress, inducible ischemia, CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DSE | Patients, who underwent Dobutamine Stress Echocardiography (DSE) | |
| DSCMR | Patients, who underwent Dobutamine Stress Cardiac Magnetic Resonance (DSCMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death and nonfatal myocardial infarction (MACEs)
Measured: 4-6 years of follow-up
Secondary outcomes (1)
Late revascularization (90 days after the MR-examination)
Measured: 4-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJan 2001
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GKorosoglou, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568502
- Sponsor's protocol ID
- NCT00837006
- Status last verified
- Mar 2012
- First submitted
- 29 Mar 2012
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dobutamine Stress Cardiac Magnetic Resonance Versus Echocardiography for the Assessment of Outcome. Are the Two Imaging Modalities Comparable?
- ClinicalTrials.gov ID
- NCT01568502
- Acronym / sponsor ID
- NCT00837006
- Conditions
- Coronary Artery Disease
- Keywords
- dobutamine stress, inducible ischemia, CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,008 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dobutamine stress echocardiography (DSE) and cardiac magnetic resonance (DCMR) are both established non-invasive techniques, used in the clinical routine for the diagnostic classification and risk stratification of patients with suspected or known coronary artery disease (CAD).
In this regard, regional wall motion abnormalities (WMA) during dobutamine stress, precede the development of ST-segment depression and anginal symptoms, enabling the detection of anatomically significant CAD and the assessment of clinical outcomes.
In a head-to-head comparison between the 2 techniques, favourable diagnostic characteristics in terms of higher sensitivity and accuracy were noted for DCMR compared to DSE.
Although it has been reported that stress induced WMA both in DCMR and in DSE are independent predictors for hard cardiac events such as cardiac death or myocardial infarction, the value of the 2 techniques for the risk stratification of patients with CAD has not been compared to each other so far.
Comparison of these 2 non-invasive techniques is important, because referring physicians need to know which modality is more reliable for the identification of patients at higher risk for subsequent cardiac events, who would benefit from early invasive therapy.
In the investigators study the investigators therefore sought to compare the ability of DSE versus DCMR to predict subsequent hard cardiac events and revascularization procedures in a patient cohort with high CAD prevalence. Their predictive value was compared to that of conventional atherogenic risk factors and to resting WMA. In addition, the investigators sought to determine if both techniques are equally suitable for structuring invasive or conservative treatment according to the presence or absence of inducible ischemia, respectively.
Detailed description
Background: Both DSE and DCMR are implemented in the daily diagnostic work-up of patients with ischemic heart disease. Although DCMR was previously shown to aid the diagnostic classification of patients with suspected CAD with higher sensitivity and accuracy compared to that provided by DSE, the value of the 2 techniques for the risk stratification of patients with CAD has not been investigated so far.
Methods: Patients with suspected or known CAD underwent either DSE or DCMR for clinical reasons using the same standardised high-dose dobutamine/atropine protocol. Patient matching was performed for age, gender and coronary risk factors. Wall motion was assessed at rest and during maximum stress, and outcome data including cardiac death and non-fatal myocardial infarction (defined as hard cardiac events) and 'late' revascularization performed >90 days after the MR-scans were prospectively collected at least 6 months after DSE or DCMR.
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 is collected 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSE | – | –Patients, who underwent Dobutamine Stress Echocardiography (DSE) |
| DSCMR | – | –Patients, who underwent Dobutamine Stress Cardiac Magnetic Resonance (DSCMR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred to our institution for clinically indicated dobutamine stress testing (either DSCMR or DSE) due to suspected or known CAD(with/without prior revascularization and with/without history of previous myocardial infarction).
Key inclusion criteria (1 listed)
- written informed consent before the DSE or DSCMR-examination
Key exclusion criteria (5 listed)
- unstable angina
- severe arterial hypertension (>200/120mmHg)
- moderate or severe valvular disease
- general contraindications to dobutamine stress echocardiography:poor echogenic windows limiting endocardial border detection in ≥2 myocardial segments
- general contraindications to dobutamine stress cardiac magnetic resonance: implanted pacemakers or cardioverter defibrillator, claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac death and nonfatal myocardial infarction (MACEs)
Time frame: 4-6 years of follow-up
1 secondary outcome
Late revascularization (90 days after the MR-examination)
Time frame: 4-6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University Hospital Heidelberg at 1 site in Germany.
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 1 inclusion and 5 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 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does the primary outcome measure?
Cardiac death and nonfatal myocardial infarction (MACEs) (time frame: 4-6 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2012.