Study to Develop a Non-invasive Marker for Monitoring Myocardial Fibrosis (SCAR)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01230918 |
Recruitment Status
:
Terminated
(Costs of study procedures has changed and escalated and became prohibitive.)
First Posted
: October 29, 2010
Last Update Posted
: April 24, 2017
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | October 28, 2010 | |||
First Posted Date ICMJE | October 29, 2010 | |||
Last Update Posted Date | April 24, 2017 | |||
Study Start Date ICMJE | May 2011 | |||
Actual Primary Completion Date | April 20, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
TcNC100692 uptake [ Time Frame: 3 hours ] The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy.
|
|||
Original Primary Outcome Measures ICMJE |
TcNC100692 uptake The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy.
|
|||
Change History | Complete list of historical versions of study NCT01230918 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study to Develop a Non-invasive Marker for Monitoring Myocardial Fibrosis | |||
Official Title ICMJE | Technetium-NC100692 SCintigraphy to Detect avB3 Integrin Expression as a mARker of Fibrosis in Hypertrophic Cardiomyopathy and Acute Coronary Syndrome: the SCAR Study | |||
Brief Summary | The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI) can serve as a marker for scar formation as detected by contrast-enhanced MRI during the process of myocardial remodelling after the ischemic insult. Comparison of ACS and HCM Populations: The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy. The primary hypothesis is that since fibrogenesis is known to occur most intensely in the first days to weeks post myocardial infarction, while it is a more protracted, less predictable process in HCM, there will be significantly more TcNC100692 uptake in the early post-ACS population than in the HCM population. Control Population: Normal control images will allow for differentiation of uptake in the myocardium. |
|||
Detailed Description | HCM Population: The primary objective is to determine whether fibrosis detected by MRI and 99mTc-NC100692 uptake in patients with HCM are associated. The secondary objective is to determine whether 99mTc-NC100692 uptake correlates on a segmental basis with fibrosis visualised by late Gd-enhancement MRI. The tertiary objective is to evaluate the relationship between the extent of fibrosis assessed by 99mTc-NC100692 uptake and mean longitudinal strain as determined by speckle tracking echocardiography. The primary hypothesis is that there is an increased uptake of 99mTc-NC100692 in patients with HCM fibrosis detected by MRI. The secondary hypothesis is that the location and extent of increased 99mTc-NC100692 uptake will correlate with localization and extent measurements of fibrosis by Gd-enhanced magnetic resonance imaging. The tertiary hypothesis is that the extent of fibrosis assessed by the number of segments with and the magnitude of 99mTc NC100692 uptake will correlate with mean longitudinal strain as determined by speckle tracking echocardiography. ACS Population: The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI) can serve as a marker for scar formation as detected by contrast-enhanced MRI during the process of myocardial remodelling after the ischemic insult. The primary hypothesis is that there is an increased uptake of 99Technetium-NC100692 in patients following an ACS event (MI) and that the location and extent of increased 99Technetium-NC100692 uptake will correlate with the presence and extent of scar as detected by contrast-enhanced magnetic resonance imaging. Normal Control Population: Preliminary analysis of images from HCM population showed a diffuse, low grade uptake of 99Technetium-NC100692 in non-hypertrophied myocardial segments. Although not entirely unexpected, comparison with control images will allow for quantification of low grade fibrosis and low grade uptake. |
|||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
|||
Condition ICMJE |
|
|||
Intervention ICMJE | Radiation: 99mTc-NC100692
HCM and ACS subjects: 99mTc-NC100692 SPECT scan, CMR and echocardiography images will be obtained and compared. Normal control: 99mTc-NC100692 SPECT scan, CMR and echocardiography imaging obtained for comparison with HCM and ACS images. |
|||
Study Arms | Experimental: Diagnostic Imaging
A single dose of 800 to 1100 mBq of 99mTc-NC100692 radiopharmaceutical will be injected. Serial cardiac nuclear imaging will be done over a 3 hour period.
Intervention: Radiation: 99mTc-NC100692 |
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Estimated Enrollment ICMJE |
120 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | April 20, 2017 | |||
Actual Primary Completion Date | April 20, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | HCM Population: Inclusion Criteria:
Exclusion Criteria:
ACS Population: Inclusion Criteria:
Exclusion Criteria:
Normal Control: Inclusion Criteria:
Exclusion Criteria:
All populations: Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01230918 | |||
Other Study ID Numbers ICMJE | HI Protocol #2009641-01H | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Terrence Ruddy, Ottawa Heart Institute Research Corporation | |||
Study Sponsor ICMJE | Ottawa Heart Institute Research Corporation | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Ottawa Heart Institute Research Corporation | |||
Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |