Status:
COMPLETED
Study of 99mTc-glucarate to Detect Acute Coronary Syndrome in Chest Pain Patients.
Lead Sponsor:
Molecular Targeting Technologies, Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Yale University
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 w...
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). Differentiatin...
Eligibility Criteria
Inclusion
- Chest pain of recent onset (less than 24 hours) and of greater than 5-minute duration, consistent with ACS;
- History of CAD;
- Creatinine level less than 3.5 mg per deciliter;
- Female patients who are: surgically sterile (hysterectomy or bilateral tubule libation), at least one year post-menopausal, or have a negative pregnancy test on the day of treatment; and
- Written informed consent.
- This research is being supported by the NIH/NHLBI which requires a minimum 50% participation from women. Efforts should be made to enroll equal numbers of men and women at each clinical site.
Exclusion
- ECG changes diagnostic of AMI;
- A cardiac revascularization procedure within the last 2 weeks (non-revascularization procedures such as cardiac catheterization, stress test or echocardiography are acceptable);
- An alternate diagnosis more probable than ACS;
- Presence of pericarditis, myocarditis, acute aortic dissection, pneumothorax, or pulmonary embolism (PE);
- Patients with uncontrolled severe heart failure at the time of enrollment (NYHA class III and IV).
- Other serious or life-threatening disease that might preclude a subject from completing this study;
- Clinically essential procedures with which this protocol may interfere;
- Previous 99mTc-based diagnostic test within the last 24 hours;
- Female subjects who are pregnant or lactating;
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00614354
Start Date
October 1 2008
End Date
September 1 2010
Last Update
October 24 2013
Active Locations (4)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Yale University
New Haven, Connecticut, United States, 06520
3
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213