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

Mass General Brigham

Status: Completed

Conditions: Heart Failure - NYHA II - IV; Wide QRS Complex

Treatments: Other: Randomization of Pre-knowledge of CT coronary venography

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01097733

2008P000555

1K23HL098370 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Pre-procedural cardiac CT

Description:

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.

Treatment:

Other: Randomization of Pre-knowledge of CT coronary venography