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

Wide QRS Complex Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097733
• Other study ID #: 2008P000555
• Secondary ID: 1K23HL098370
• Status: Completed
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: September 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure - NYHA II - IV
• Wide QRS Complex

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Abbott Medical Devices, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implantation and fluoroscopy time and radiation exposure	Implantation time, fluoroscopy time, and radiation exposure	During time of implant
Other	Agreement between CT venography and invasive coronary venography		within the CT venography and invasive coronary venography
Primary	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	Major adverse cardiovascular events (MACE)	MACE defined as composite endpoints of death, cardiac transplant, left ventricular assist device, and HF hospitalization	2 years
Secondary	Secondary endpoints	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	6 months