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

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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
Sponsor:
Collaborators:
Brigham and Women's Hospital
St. Jude Medical
Information provided by (Responsible Party):
Jagmeet Singh, Massachusetts General Hospital

Brief Summary:
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 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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. Implantation and fluoroscopy time and radiation exposure [ Time Frame: During time of implant ]
    Implantation time, fluoroscopy time, and radiation exposure

  2. Agreement between CT venography and invasive coronary venography [ Time Frame: within the CT venography and invasive coronary venography ]

Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
St. Jude Medical
Investigators
Principal Investigator: Jagmeet P Singh, MD, PhD Massachusetts General Hospital

Publications:
Responsible Party: Jagmeet Singh, Jagmeet Singh, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01097733     History of Changes
Other Study ID Numbers: 2008P000555
1K23HL098370 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases