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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
St. Jude Medical
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01097733
First received: March 25, 2010
Last updated: March 31, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition
Heart Failure - NYHA III or IV
Wide QRS Complex

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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

whole blood


Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
CRT patients
CRT patients will undergo cardiac CT pre-implantation to assess for dyssynchrony, scar, and coronary venous anatomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatient or inpatient heart failure patients scheduled for CRT implantation

Criteria

Inclusion Criteria:

  • Older than 18 years of age
  • Ability to provide informed consent
  • Planned CRT implantation
  • NYHA Functional Class III-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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097733

Contacts
Contact: Jagmeet P Singh, M.D. Ph.D. 617-726-4662 jsingh@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jagmeet P Singh, M.D. Ph.D.     617-726-4662     jsingh@partners.org    
Principal Investigator: Jagmeet P Singh, M.D. Ph.D.            
Sponsors and Collaborators
Massachusetts General Hospital
St. Jude Medical
Investigators
Principal Investigator: Jagmeet P Singh, MD, PhD Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Jagmeet P. Singh, M.D. Ph.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01097733     History of Changes
Other Study ID Numbers: 2008P000555, 1K23HL098370
Study First Received: March 25, 2010
Last Updated: March 31, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013