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| [ Print-friendly version ] |
| Effect of targeting left ventricular lead position on the rate of response to resynchronisation therapy in patients with Coronary Artery Disease |
| ISRCTN | ISRCTN91938977 |
| ClinicalTrials.gov identifier | NCT00399594 |
| Public title | Effect of targeting left ventricular lead position on the rate of response to resynchronisation therapy in patients with Coronary Artery Disease |
| Scientific title | Investigating Non-response to Cardiac Resynchronisation: Evaluation of Methods to Eliminate Non-response and Target Appropriate Lead location in patients with Coronary Artery Disease |
| Acronym | INCREMENTAL-CAD |
| Serial number at source | MCT-87465 |
| Study hypothesis |
Primary hypothesis:
Echo-guided left ventricular (LV) lead placement will result in an increased probability of cardiac resynchronisation therapy (CRT) response at 9 months versus usual (postero-lateral/lateral wall) lead placement. Secondary aims: Assess the utility of the following baseline variables to predict CRT response: 1. Greater than or equal to 15% myocardial scarring on cardiac magnetic resonance imaging (MRI) 2. Greater than or equal to four viable segments on dobutamine echo 3. N-terminal B-type natriuretic peptide levels |
| Ethics approval | Ethics approval received from the Research Ethics Board of University of Calgary on the 18th November 2004 (ref: 18058). |
| Study design | Interventional, double blind (participant, caregiver, outcomes assessor) randomised parallel assignment |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Coronary artery disease |
| Participants - inclusion criteria |
1. Left ventricular ejection fraction (LVEF) less than or equal to 0.35 measured within three months of enrolment
2. Specific Activity Scale (SAS) class 3 or 4 symptoms (moderate to severe functional capacity limitation due to heart failure) within 1 month of enrolment 3. QRS width greater than 120 ms 4. Confirmed dyssynchrony on screening echo 5. Documented history of ischaemic heart disease (prior myocardial infarction, prior coronary artery bypass, prior coronary angioplasty, or imaging confirmation [angiogram, cardiac MRI]) 6. On stable doses of angiotensin converting enzyme (ACE) inhibitor or angiotensin II blocker and a beta-blocker for greater than or equal to two months unless medically contra-indicated 7. Controlled heart rate if in permanent atrial fibrillation (AF) (resting rate less than 70 and maximal rate less than 120 bpm) 8. Patients aged 18 years or older |
| Participants - exclusion criteria |
1. Unable or unwilling to provide informed consent
2. Medical condition other than heart failure likely to cause death within 12 months 3. Cardiac transplant planned within six months 4. Known contra-indication to transvenous CRT device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of transvenous leads) 5. Clinically significant myocardial infarction within last two months 6. Coronary artery bypass graft surgery less than or equal to two months or coronary angioplasty less than or equal to one month |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 30/03/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 300 |
| Interventions |
Experimental intervention:
Targeted LV lead placement based on results of echo imaging. Control intervention: Usual LV lead placement. The duration of each intervention/follow-up in 9 months in both groups. |
| Primary outcome measure(s) | CRT response (greater than or equal to 10% relative reduction in left ventricular end systolic volume and greater than or equal to one Specific Activity Scale class reduction) at 9 months. |
| Secondary outcome measure(s) |
1. Clinical events (mortality and hospitalisation) from implant until 9 months
2. Safety (procedural time, contrast use, fluoroscopy time, procedural complications - minor and severe) from implant until 9 months 3. Pacing efficacy (pacing thresholds) from implant until 9 months |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87465) |
| Trial website | |
| Publications | |
| Contact name | Dr Derek V Exner |
| Address |
G208, 3330 Hospital Drive NW
Health Sciences Centre University of Calgary |
| City/town | Calgary, Alberta |
| Zip/Postcode | T2N 4N1 |
| Country | Canada |
| Tel | +1 403 220 3219 |
| Fax | +1 403 210 8140 |
| exner@ucalgary.ca | |
| Sponsor | University of Calgary (Canada) |
| Address | 2500 University Drive N.W. |
| City/town | Calgary, Alberta |
| Zip/Postcode | T2N 1N4 |
| Country | Canada |
| Sponsor website: | http://www.ucalgary.ca/ |
| Date applied | 17/06/2008 |
| Last edited | 18/06/2008 |
| Date ISRCTN assigned | 17/06/2008 |
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