Ignite Creation Date:
2024-05-05 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00614354
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2008-01-30
Brief Title:
Study of 99mTc-glucarate to Detect Acute Coronary Syndrome in Chest Pain Patients
Sponsor:
Molecular Targeting Technologies Inc
Organization:
Molecular Targeting Technologies Inc
Study Overview
Official Title:
Phase II Study of 99mTc-glucarate in Chest Pain Patients Suspected With ACS With no Obvious Signs of AMI and With Known Previous CAD
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to study the ability of a radioactive drug called Technetium Glucarate to detect whether the cause of chest pain in patients entering the emergency department with no obvious signs of heart attack is due to a condition called Acute Coronary Syndrome ACS The drug will be injected intravenously After one or two hours the patient will undergo an imaging procedure to detect if the drug has accumulated in the heart Uptake of the radioactive drug in the heart is indicative of reduced blood flow to the heart
Detailed Description:
Acute coronary syndrome encompasses a range of coronary artery diseases including unstable angina and both ST-segment elevation and non-ST-segment elevation myocardial infarction MI Differentiating ACS from noncardiac chest pain remains a challenge in the emergency department ED Myocardial perfusion imaging MPI for ischemia has been used to rule ACS in or out among chest pain patients with nondiagnostic ECGs upon presentation to the ED Several studies have shown a high negative predictive value of MPI for ruling out acute ischemia in the emergency setting Although myocardial imaging with perfusion agents provides important information for risk-stratifying stable post-ACS patients this method is of limited value in patients with prior history of CAD since these patients will often have abnormal resting perfusion patterns thereby precluding the ability to differentiate old infarcts from new ischemic events 99mTc-glucarate does not detect old MIs and thus should provide an improvement in specificity in the imaging of ACS patients with previous CAD
This study proposes to extend the evaluation of 99mTc-glucarate imaging by studying its ability to detect ACS in chest pain patients with no obvious signs of AMI but with known CAD in the setting of the ED Unlike MPI 99mTc-glucarate imaging will not detect old MIs thereby providing an advantage in specificity of the technique
This study proposes to extend the evaluation of 99mTc-glucarate imaging by studying its ability to detect ACS in chest pain patients with no obvious signs of AMI but with known CAD in the setting of the ED Unlike MPI 99mTc-glucarate imaging will not detect old MIs thereby providing an advantage in specificity of the technique
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R44HL062770-06 | NIH | None | httpsreporternihgovquickSearch5R44HL062770-06 |