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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

99mTc-glucarate solution

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring 99mTc-glucarate imaging to detect acute coronary syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

University of Alabama at Birmingham
Yale University
University Hospital Case Medical Center
University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Readers will assess images as either positive or negative and note the location of uptake.

Secondary Outcome Measures

Full Information

NCT ID

NCT00614354

First Posted

January 30, 2008

Last Updated

October 23, 2013

Sponsor

Molecular Targeting Technologies, Inc.

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Yale University, University of Pittsburgh, University of Alabama at Birmingham, University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00614354

Brief Title

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

Official Title

Phase II Study of 99mTc-glucarate in Chest Pain Patients Suspected With ACS With no Obvious Signs of AMI and With Known Previous CAD.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Molecular Targeting Technologies, Inc.

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Yale University, University of Pittsburgh, University of Alabama at Birmingham, University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

99mTc-glucarate imaging to detect acute coronary syndrome

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

99mTc-glucarate solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Readers will assess images as either positive or negative and note the location of uptake.

Time Frame

Immediately and end of enrolement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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;

Overall Study Officials: