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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure - NYHA II - IV Wide QRS Complex

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Randomization of Pre-knowledge of CT coronary venography

Intervention Type OTHER

Interventions

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Randomization of Pre-knowledge of CT coronary venography

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No