Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy (DIRECT)
Cardiac Resynchronization Therapy (CRT) is a widely accepted treatment that has led to improved clinical outcomes for patients with refractory congestive heart failure (CHF), systolic dysfunction, and wide QRS duration. However, it requires implantation of an expensive device ($30,000) and about 1/3 of patients do not have clinical improvement. Inadequate amounts of LV dyssynchrony or suboptimal lead placement may limit clinical response. Dual-Source computed tomography (DSCT) allows for subtle detection during myocardial contraction for assessing LV dyssynchrony, and can also assess coronary venous anatomy and scar burden. Thus DSCT may be the ideal noninvasive modality to predict response to CRT.
Heart Failure - NYHA II - IV
Wide QRS Complex
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy|
- Clinical Response to CRT [ Time Frame: 6 months post implantation of CRT ] [ Designated as safety issue: No ]The clinical response to CRT will be adjudicated by two experienced cardiologists taking into account left ventricular ejection fraction, NYHA functional class, and patient global assessment score.
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
CRT patients will undergo cardiac CT pre-implantation to assess for dyssynchrony, scar, and coronary venous anatomy.
|Contact: Jagmeet P Singh, M.D. Ph.D.||firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jagmeet P Singh, M.D. Ph.D. 617-726-4662 email@example.com|
|Principal Investigator: Jagmeet P Singh, M.D. Ph.D.|
|Principal Investigator:||Jagmeet P Singh, MD, PhD||Massachusetts General Hospital|