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Completed

NCT Number: NCT01097733

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

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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Key information

Conditions

Heart Failure - NYHA II - IV Wide QRS Complex

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Randomization of Pre-knowledge of CT coronary venography

Other

Primary outcomes

  1. Clinical Response to CRT

    Time frame: 6 months post implantation of 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.

Secondary outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: 2 years

    MACE defined as composite endpoints of death, cardiac transplant, left ventricular assist device, and HF hospitalization

  2. Secondary endpoints

    Time frame: 6 months

    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

Other outcomes

  1. Implantation and fluoroscopy time and radiation exposure

    Time frame: During time of implant

    Implantation time, fluoroscopy time, and radiation exposure

  2. Agreement between CT venography and invasive coronary venography

    Time frame: within the CT venography and invasive coronary venography

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Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Abbott Medical Devices
  • Brigham and Women's Hospital

Registry information

Acronym: DIRECT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2010
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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