Prognostic Value of High Dose Dobutamine Stress Magnetic Resonance Imaging

NCT00837005 | Completed

• 1 other identifier: DOBU-STRESS01
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease (CAD)

Keywords

dobutamine stress; inducible ischemia; CAD

Outcome Measures

Primary Outcomes (1)

• Cardiac death and nonfatal myocardial infarction (MACEs)

  2-5 years of follow-up

Secondary Outcomes (1)

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

  2-5 yrs.

Study Arms (2)

1

Patients with suspected CAD

2

Patients with known CAD and suspected ischemia.

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 MRI 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 MR-examination

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University of Heidelberg, Department of Cardiology

Heidelberg, 69120, Germany

Location

Related Publications (1)

• Korosoglou G, Elhmidi Y, Steen H, Schellberg D, Riedle N, Ahrens J, Lehrke S, Merten C, Lossnitzer D, Radeleff J, Zugck C, Giannitsis E, Katus HA. Prognostic value of high-dose dobutamine stress magnetic resonance imaging in 1,493 consecutive patients: assessment of myocardial wall motion and perfusion. J Am Coll Cardiol. 2010 Oct 5;56(15):1225-34. doi: 10.1016/j.jacc.2010.06.020.

  PMID: 20883929 DERIVED

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.

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: January 1, 2005
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

DE (1)