- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01097733
Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy (DIRECT)
September 30, 2022 updated by: Jagmeet Singh, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Outpatient or inpatient heart failure patients scheduled for CRT implantation
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 months post implantation of CRT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
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
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implantation and fluoroscopy time and radiation exposure
Time Frame: During time of implant
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Implantation time, fluoroscopy time, and radiation exposure
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During time of implant
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Agreement between CT venography and invasive coronary venography
Time Frame: within the CT venography and invasive coronary venography
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within the CT venography and invasive coronary venography
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jagmeet P Singh, MD, PhD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2009
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
March 25, 2010
First Submitted That Met QC Criteria
March 31, 2010
First Posted (Estimate)
April 2, 2010
Study Record Updates
Last Update Posted (Actual)
October 3, 2022
Last Update Submitted That Met QC Criteria
September 30, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008P000555
- 1K23HL098370 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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