Condition:
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.
Dates: October 2008 -
Study Status: Recruiting
Ages Eligible: 18 Years and older
Gender Eligible: Both
Inclusion Criteria:
- 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 Criteria:
- 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;
Sponsors:
Phase: Phase 2
First Received: January 30, 2008
Last Updated: May 17, 2010
Clinicaltrials.gov ID:
NCT00614354
Study HIC # 0707002878
Condition:
Intervention: Drug: 99mTc-glucarate solution
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.
Dates: October 2008 -
Study Status: Recruiting
Ages Eligible: 18 Years and older
Gender Eligible: Both
Inclusion Criteria:
- 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 Criteria:
- 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;
Sponsors:
Phase: Phase 2
First Received: January 30, 2008
Last Updated: May 17, 2010
Clinicaltrials.gov ID:
NCT00614354
Study HIC # 0707002878
Ajay V. Srivastava, MD
203-412-9571
ajay.v.srivastava@yale.edu
Albert J. Sinusas, MD
203-785-3155
albert.sinusas@yale.edu
Jeffrey A Mattis, Ph.D.
610-738-7938 Ext. 106
jmattis@mtarget.com
Sinusas, Albert John
Principal Investigator
HIC # 0805003779
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