Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy (DIRECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
St. Jude Medical
Information provided by (Responsible Party):
Jagmeet Singh, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01097733
First received: March 25, 2010
Last updated: June 22, 2014
Last verified: June 2014

March 25, 2010
June 22, 2014
February 2009
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01097733 on ClinicalTrials.gov Archive Site
  • Major adverse cardiovascular events (MACE) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    MACE defined as composite endpoints of death, cardiac transplant, left ventricular assist device, and HF hospitalization
  • Secondary endpoints [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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
Not Provided
  • Implantation and fluoroscopy time and radiation exposure [ Time Frame: During time of implant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
Not Provided
 
Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy
Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Probability Sample

Outpatient or inpatient heart failure patients scheduled for CRT implantation

  • Heart Failure - NYHA II - IV
  • Wide QRS Complex
Other: Randomization of Pre-knowledge of CT coronary venography
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.
Intervention: Other: Randomization of Pre-knowledge of CT coronary venography
Truong QA, Singh JP, Cannon CP, Sarwar A, Nasir K, Auricchio A, Faletra FF, Sorgente A, Conca C, Moccetti T, Handschumacher M, Brady TJ, Hoffmann U. Quantitative analysis of intraventricular dyssynchrony using wall thickness by multidetector computed tomography. JACC Cardiovasc Imaging. 2008 Nov;1(6):772-81.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2016
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Older than 18 years of age
  • Ability to provide informed consent
  • Planned CRT implantation
  • NYHA Functional Class II-IV heart failure
  • Echo Ejection Fraction less than or equal to 35%
  • QRS duration greater than or equal to 120 ms
  • Normal or mildly reduced kidney function (estimated serum creatinine less than or equal to 1.5 mg/dL or less than or equal to 1.3 mg/dL for diabetic subjects on metformin
  • For diabetic subjects on glucophage (metformin) they will be required to stop glucophage (metformin) for at least 48 hours after the administration of contrast.

Exclusion Criteria:

  • Known allergy to iodine or iodinated contrast
  • Chronic persistent atrial fibrillation
  • Pregnancy or unknown pregnancy status
  • Subjects on glucophage (metformin) therapy that are unable or unwilling to discontinue therapy for 48 hours after CT scan
  • Known inadequate venous access for appropriate IV caliber placement
  • Iodinated contrast administration within the past 48 hours
  • Subjects who cannot hold their breath for 10-15 seconds
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01097733
2008P000555, 1K23HL098370
No
Jagmeet Singh, Massachusetts General Hospital
Massachusetts General Hospital
  • Brigham and Women's Hospital
  • St. Jude Medical
Principal Investigator: Jagmeet P Singh, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP