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 number	NCT00399594
Secondary identifying numbers	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

G208, 3330 Hospital Drive NW
Health Sciences Centre
University of Calgary
Calgary, Alberta
T2N 4N1
Canada

Phone	+1 403 220 3219
Email	exner@ucalgary.ca

Study information

Study design	Interventional, double blind (participant, caregiver, outcomes assessor) randomised parallel assignment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/09/2008
Completion date	30/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

University of Calgary (Canada)
University/education

2500 University Drive N.W.
Calgary, Alberta
T2N 1N4
Canada

Website	http://www.ucalgary.ca/
"ROR"	https://ror.org/03yjb2x39

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-87465)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/02/2019: No publications found. Verifying results with principal investigator.