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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL098370 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Abbott Medical Devices | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Randomization of Pre-knowledge of CT coronary venography | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events (MACE) | MACE defined as composite endpoints of death, cardiac transplant, left ventricular assist device, and HF hospitalization | 2 years |
| Secondary endpoints |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation and fluoroscopy time and radiation exposure | Implantation time, fluoroscopy time, and radiation exposure | During time of implant |
| Agreement between CT venography and invasive coronary venography |
Inclusion Criteria:
Exclusion Criteria:
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Outpatient or inpatient heart failure patients scheduled for CRT implantation
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| Name | Affiliation | Role |
|---|---|---|
| Jagmeet P Singh, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19212461 | Background | 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. | |
| 31865389 | Derived | 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. |
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Whole blood
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 |
| within the CT venography and invasive coronary venography |
| 29572087 | 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. |