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

NCT01097733 | Completed

• 2 other identifiers: 2008P0005551K23HL098370
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure - NYHA II - IV; Wide QRS Complex

Outcome Measures

Primary Outcomes (1)

• Clinical Response to 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.

  6 months post implantation of CRT

Secondary Outcomes (2)

• Major adverse cardiovascular events (MACE)

  2 years

• Secondary endpoints

  6 months

Other Outcomes (2)

• Implantation and fluoroscopy time and radiation exposure

  During time of implant

• Agreement between CT venography and invasive coronary venography

  within the CT venography and invasive coronary venography

Study Arms (1)

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

Interventions

Randomization of Pre-knowledge of CT coronary venography OTHER

Pre-procedural cardiac CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatient or inpatient heart failure patients scheduled for CRT implantation

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Abbott Medical Devices: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• 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.

  PMID: 19212461 BACKGROUND

• 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.

  PMID: 31865389 DERIVED

• 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.

  PMID: 29572087 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Study Officials

• Jagmeet P Singh, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jagmeet Singh, MD

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: April 2, 2010
• Study Start: February 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

US (1)