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

NCT00614354 | Completed Phase 2

• 2 other identifiers: MTTI ACS 2015R44HL062770-06
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Coronary Syndrome

Keywords

99mTc-glucarate imaging to detect acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

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

  Immediately and end of enrolement

Study Arms (1)

1

EXPERIMENTAL

Drug: 99mTc-glucarate solution

Interventions

99mTc-glucarate solution DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

University Hospital Case Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Albert J. Sinusas, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Diwakar Jain, MD

  Drexel University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 13, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 24, 2013

Record last verified: 2012-10

Locations

US (4)