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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: 99mTc-glucarate solution

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospital Case Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Readers will assess images as either positive or negative and note the location of uptake.	Immediately and end of enrolement

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: January 30, 2008
• First Submitted That Met QC Criteria: February 12, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Estimate): October 24, 2013
• Last Update Submitted That Met QC Criteria: October 23, 2013
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: 99mTc-glucarate imaging to detect acute coronary syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Disease; Syndrome; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: MTTI ACS 201; 5R44HL062770-06 (U.S. NIH Grant/Contract)