Contact information
Type
Scientific
Primary contact
Dr Derek V Exner
ORCID ID
Contact details
G208
3330 Hospital Drive NW
Health Sciences Centre
University of Calgary
Calgary
Alberta
T2N 4N1
Canada
+1 403 220 3219
exner@ucalgary.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00399594
Protocol/serial number
MCT-87465
Study information
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
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
Research Ethics Board of University approved of Calgary on the 18th November 2004 (ref: 18058).
Study design
Interventional, double blind (participant, caregiver, outcomes assessor) randomised parallel assignment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/09/2008
Overall trial end date
30/03/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/09/2008
Recruitment end date
30/03/2012
Locations
Countries of recruitment
Canada
Trial participating centre
G208, 3330 Hospital Drive NW
Calgary, Alberta
T2N 4N1
Canada
Sponsor information
Organisation
University of Calgary (Canada)
Sponsor details
2500 University Drive N.W.
Calgary
Alberta
T2N 1N4
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87465)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary