NCT00758654

Brief Summary

The purpose of this study is to compare the diagnostic value of SENC to that provided by conventional wall motion analysis for the detection of inducible ischemia during DS-MRI.High-dose dobutamine stress magnetic resonance imaging (DS-MRI) is safe and feasible for the diagnosis of coronary artery disease (CAD) in humans. However, the assessment of cine scans relies on the visual interpretation of regional wall motion, which is subjective. Recently, Strain-Encoded MRI (SENC) has been proposed for the direct color-coded visualization of myocardial strain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

4 years

First QC Date

September 23, 2008

Last Update Submit

March 28, 2012

Conditions

Keywords

myocardial strainStrain-Encoded MRIdobutamine stress MRIischemiastrain rate reserve

Outcome Measures

Primary Outcomes (1)

  • Detection of coronary artery disease (>50% diameter stenosis) by invasive angiography

    3 weeks

Secondary Outcomes (1)

  • Long-term mortality and MACE

    2 years

Study Arms (2)

1

Patients with suspected or known stable coronary artery disease

2

Healthy subjects as a control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients with suspected or known coronary artery disease and healthy volunteers serving as a contol group.

You may qualify if:

  • Suspected or known coronary artery disease

You may not qualify if:

  • General contraindication for a dobutamine stress or for an MRI examination
  • Age \< 18 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg, Department of Cardiology

Heidelberg, 69120, Germany

Location

Related Publications (2)

  • Korosoglou G, Gitsioudis G, Voss A, Lehrke S, Riedle N, Buss SJ, Zugck C, Giannitsis E, Osman NF, Katus HA. Strain-encoded cardiac magnetic resonance during high-dose dobutamine stress testing for the estimation of cardiac outcomes: comparison to clinical parameters and conventional wall motion readings. J Am Coll Cardiol. 2011 Sep 6;58(11):1140-9. doi: 10.1016/j.jacc.2011.03.063.

  • Korosoglou G, Lehrke S, Wochele A, Hoerig B, Lossnitzer D, Steen H, Giannitsis E, Osman NF, Katus HA. Strain-encoded CMR for the detection of inducible ischemia during intermediate stress. JACC Cardiovasc Imaging. 2010 Apr;3(4):361-71. doi: 10.1016/j.jcmg.2009.11.015.

MeSH Terms

Conditions

Coronary Artery DiseaseIschemia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

September 23, 2008

First Posted

September 25, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations