Clinical trial NCT01097733: Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy
Official title: Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure - NYHA II - IV
Wide QRS Complex
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Abbott Medical Devices
First posted: 2010-04-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient or inpatient heart failure patients scheduled for CRT implantation

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.


Eligibility 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

Primary outcomes:
measure: Clinical Response to CRT
timeFrame: 6 months post implantation of CRT
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 2 years
measure: Secondary endpoints
timeFrame: 6 months
Other outcomes:
measure: Implantation and fluoroscopy time and radiation exposure
timeFrame: During time of implant
measure: Agreement between CT venography and invasive coronary venography
timeFrame: within the CT venography and invasive coronary venography
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jagmeet P Singh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.jcmg.2008.07.014.
citation: Galand V, Ghoshhajra B, Szymonifka J, Das S, Orencole M, Barre V, Martins RP, Leclercq C, Hung J, Truong QA, Singh JP. Left ventricular wall thickness assessed by cardiac computed tomography and cardiac resynchronization therapy outcomes. Europace. 2020 Mar 1;22(3):401-411. doi: 10.1093/europace/euz322.
citation: Truong QA, Szymonifka J, Picard MH, Thai WE, Wai B, Cheung JW, Heist EK, Hoffmann U, Singh JP. Utility of dual-source computed tomography in cardiac resynchronization therapy-DIRECT study. Heart Rhythm. 2018 Aug;15(8):1206-1213. doi: 10.1016/j.hrthm.2018.03.020. Epub 2018 Mar 20.