Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy (DIRECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01097733|
Recruitment Status : Unknown
Verified June 2014 by Jagmeet Singh, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 2, 2010
Last Update Posted : June 24, 2014
|Condition or disease||Intervention/treatment|
|Heart Failure - NYHA II - IV Wide QRS Complex||Other: Randomization of Pre-knowledge of CT coronary venography|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2016|
Pre-procedural cardiac CT
CRT patients will undergo pre-procedural cardiac CT to assess for dyssynchrony, scar, and coronary venous anatomy. The CT venogram will be randomize to pre-knowledge to implanting physician or blinded. The CT dyssynchrony and scar assessment will remain blinded to caregivers and patients.
|Other: Randomization of Pre-knowledge of CT coronary venography|
- Clinical Response to CRT [ Time Frame: 6 months post implantation of CRT ]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.
- Major adverse cardiovascular events (MACE) [ Time Frame: 2 years ]MACE defined as composite endpoints of death, cardiac transplant, left ventricular assist device, and HF hospitalization
- Secondary endpoints [ Time Frame: 6 months ]Change in NYHA Functional Class, Echo volumes and ejection fraction, Minnesota Quality of Life score, 6-minute walk distance, NT-proBNP levels, and hospitalization at 6 months
- Implantation and fluoroscopy time and radiation exposure [ Time Frame: During time of implant ]Implantation time, fluoroscopy time, and radiation exposure
- Agreement between CT venography and invasive coronary venography [ Time Frame: within the CT venography and invasive coronary venography ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097733
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jagmeet P Singh, MD, PhD||Massachusetts General Hospital|