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
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: 99mTc-glucarate solution
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Molecular Targeting Technologies, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614354

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Ohio
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Molecular Targeting Technologies, Inc.
Yale University
University of Pittsburgh
University of Alabama at Birmingham
University Hospital Case 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 Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Molecular Targeting Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00614354     History of Changes
Other Study ID Numbers: MTTI ACS 201, 5R44HL062770-06
Study First Received: January 30, 2008
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Molecular Targeting Technologies, Inc.:
99mTc-glucarate imaging to detect acute coronary syndrome

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Pain
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014