Effect of targeting left ventricular lead position on the rate of response to resynchronisation therapy in patients with Coronary Artery Disease
| ISRCTN | ISRCTN91938977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91938977 |
| ClinicalTrials.gov (NCT) | NCT00399594 |
| Protocol serial number | MCT-87465 |
| Sponsor | University of Calgary (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87465) |
- Submission date
- 17/06/2008
- Registration date
- 17/06/2008
- Last edited
- 19/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Derek V Exner
Scientific
Scientific
G208, 3330 Hospital Drive NW
Health Sciences Centre
University of Calgary
Calgary, Alberta
T2N 4N1
Canada
| Phone | +1 403 220 3219 |
|---|---|
| exner@ucalgary.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, double blind (participant, caregiver, outcomes assessor) randomised parallel assignment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | INCREMENTAL-CAD |
| Study objectives | 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(s) | Research Ethics Board of University approved of Calgary on the 18th November 2004 (ref: 18058). |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | 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. |
| Intervention type | Other |
| 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. |
| Key secondary outcome measure(s) |
1. Clinical events (mortality and hospitalisation) from implant until 9 months |
| Completion date | 30/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 30/03/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
G208, 3330 Hospital Drive NW
Calgary, Alberta
T2N 4N1
Canada
T2N 4N1
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/02/2019: No publications found. Verifying results with principal investigator.
