Condition category
Circulatory System
Date applied
17/06/2008
Date assigned
17/06/2008
Last edited
06/03/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ucalgary.ca/

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

Publication citations

Additional files

Editorial Notes