Dobutamine Stress Cardiac Magnetic Resonance Versus Echocardiography for the Assessment of Outcome. Are the Two Imaging Modalities Comparable?

NCT01568502 | Completed

• 1 other identifier: NCT00837006
• Study Type: observational
• Target: 5,008
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Coronary Artery Disease

Keywords

dobutamine stress; inducible ischemia; CAD

Outcome Measures

Primary Outcomes (1)

• Cardiac death and nonfatal myocardial infarction (MACEs)

  4-6 years of follow-up

Secondary Outcomes (1)

• Late revascularization (90 days after the MR-examination)

  4-6 years

Study Arms (2)

DSE

Patients, who underwent Dobutamine Stress Echocardiography (DSE)

DSCMR

Patients, who underwent Dobutamine Stress Cardiac Magnetic Resonance (DSCMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• written informed consent before the DSE or DSCMR-examination

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University of Heidelberg, Department of Cardiology

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr. med Grigorios Korosoglou, University of Heidelberg, Department of Cardiology

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: January 1, 2001
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

DE (1)