Ignite Creation Date:
2024-05-05 @ 11:01 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01230918
Status:
TERMINATED
Last Update Posted:
2017-04-24
First Post:
2010-10-28
Brief Title:
Study to Develop a Non-invasive Marker for Monitoring Myocardial Fibrosis
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Ottawa Heart Institute Research Corporation
Study Overview
Official Title:
Technetium-NC100692 SCintigraphy to Detect avB3 Integrin Expression as a mARker of Fibrosis in Hypertrophic Cardiomyopathy and Acute Coronary Syndrome the SCAR Study
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Costs of study procedures has changed and escalated and became prohibitive
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAR
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None