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

This study has been completed.
Sponsor:
Collaborators:
Yale University
University of Pittsburgh
University of Alabama at Birmingham
University Hospital Case Medical Center
Information provided by (Responsible Party):
Molecular Targeting Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00614354
First received: January 30, 2008
Last updated: October 23, 2013
Last verified: October 2012

January 30, 2008
October 23, 2013
October 2008
September 2010   (final data collection date for primary outcome measure)
Readers will assess images as either positive or negative and note the location of uptake. [ Time Frame: Immediately and end of enrolement ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00614354 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of 99mTc-glucarate to Detect Acute Coronary Syndrome in Chest Pain Patients.
Phase II Study of 99mTc-glucarate in Chest Pain Patients Suspected With ACS With no Obvious Signs of AMI and With Known Previous CAD.

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute Coronary Syndrome
Drug: 99mTc-glucarate solution
Patients will receive a single 22 - 27 mCi bolus intravenous dose of 99mTc-glucarate solution, as soon as possible after their arrival in the emergency department or the chest pain center
Experimental: 1
Intervention: Drug: 99mTc-glucarate solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
September 2010
September 2010   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00614354
MTTI ACS 201, 5R44HL062770-06
No
Molecular Targeting Technologies, Inc.
Molecular Targeting Technologies, Inc.
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Yale University
  • University of Pittsburgh
  • University of Alabama at Birmingham
  • University Hospital Case Medical Center
Principal Investigator: Albert J. Sinusas, MD Yale University
Study Chair: Diwakar Jain, MD Drexel University
Principal Investigator: Prem Soman, MD, Ph.D. University of Pittsburgh
Principal Investigator: Ami E Iskandrian, MD University of Alabama at Birmingham
Principal Investigator: Robert S Jones, MD University Hospital Case Medical Center
Molecular Targeting Technologies, Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP