Study of 99mTc-glucarate to Detect Acute Coronary Syndrome in Chest Pain Patients.

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Targeting Technologies, Inc.
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University Hospitals Cleveland Medical Center; University of Alabama at Birmingham; University of Pittsburgh; Yale University

Criteria

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;