Accuracy of Radiolabeled Fatty Acid Analog, BMIPP, in the Late Detection of Decreased Blood Flow to the Heart (ZEUSS-ACS)

This study has been completed.
Sponsor:
Collaborator:
Molecular Insight Pharmaceuticals, Inc.
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00585663
First received: December 25, 2007
Last updated: March 25, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to:

  • evaluate the performance characteristics (sensitivity & specificity) of iodofiltic acid I-123 imaging for detection of myocardial ischemia in patients that present in the Emergency Department with suspected Acute Coronary Syndrome (ACS).
  • evaluate the safety of a single injection of iodofiltic acid I-123 in patients suspected of myocardial ischemia related to ACS.

Condition Intervention Phase
Coronary Artery Disease
Acute Coronary Syndrome
Ischemic Heart Disease
Radiation: Iodofiltic acid I-125
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase 2 Study of the Safety and Efficacy of ß-Methyl-p-[123I]-Iodophenyl-Pentadecanoic Acid for Identification of Ischemic Myocardium Using SPECT in Adults With Symptoms Consistent With Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Evaluation of sensitivity and specificity of BMIPP for the detection of coronary artery disease using cardiac catheterization or SPECT perfusion imaging with tetrofosmin or sestamibi as the gold standard [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate for adverse events associated with administration of BMIPP in patients with suspected acute coronary syndromes [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: August 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stratum A
Patients presenting with elevated cardiac biomarkers or reversible ST-segment depressions consistent with myocardial ischemia
Radiation: Iodofiltic acid I-125
Iodofiltic acid I-125 (4.0-5.0 mCi) is injected within 30 hours of the cessation of chest pain as a single injection. Single photon emission computed tomography is then performed 10-15 minutes after the injection.
Other Names:
  • BMIPP
  • Zemiva
  • Beta methyl iodophenyl pentadecanoic acid
Active Comparator: Stratum B
Patients with a known history of coronary artery disease presenting with typical anginal symptoms
Radiation: Iodofiltic acid I-125
Iodofiltic acid I-125 (4.0-5.0 mCi) is injected within 30 hours of the cessation of chest pain as a single injection. Single photon emission computed tomography is then performed 10-15 minutes after the injection.
Other Names:
  • BMIPP
  • Zemiva
  • Beta methyl iodophenyl pentadecanoic acid
Active Comparator: Stratum C
Patients with a known history of coronary artery disease presenting with atypical chest pain or patients without a history of coronary artery disease presenting with typical anginal chest pain
Radiation: Iodofiltic acid I-125
Iodofiltic acid I-125 (4.0-5.0 mCi) is injected within 30 hours of the cessation of chest pain as a single injection. Single photon emission computed tomography is then performed 10-15 minutes after the injection.
Other Names:
  • BMIPP
  • Zemiva
  • Beta methyl iodophenyl pentadecanoic acid

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chest pain occurred within the previous 24 hours
  • Provide written informed consent and are willing to comply with protocol requirements
  • ≥ 40 years of age
  • Are being evaluated for possible acute coronary syndrome

Exclusion Criteria:

  • Age < 40 years
  • Females who are pregnant or lactating
  • History of left ventricular ejection fraction (LVEF) ≤ 40%
  • History of MI
  • Acute ST segment elevation on ECG
  • Left bundle branch block on ECG
  • Known history of significant allergy to shellfish, X-ray contrast media or iodine/iodides
  • Currently or formerly on medication that targets fatty acid uptake or metabolism (e.g., ranolazine [Ranexa])
  • Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment
  • Underwent cardiac stress testing of any kind within 2 days prior to study enrollment
  • Serum creatinine level > 2.0 mg per dL
  • Received investigational compound and/or medical device within 30 days of admission into this study
  • Q-wave abnormalities consistent with previous MI
  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: NCT00585663

Locations
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Molecular Insight Pharmaceuticals, Inc.
Investigators
Study Director: Norman LaFrance, MD Molecular Insight Pharmaceuticals, Inc.
  More Information

Publications:
Responsible Party: Normal LaFrance, MD/Chief Medical Officer, Molecular Insights Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00585663     History of Changes
Other Study ID Numbers: BMIPP, MIP-BP23
Study First Received: December 25, 2007
Last Updated: March 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Coronary artery disease
Acute coronary syndrome
Ischemic heart disease
Cardiac metabolism
Fatty acids
Single photon emission computed tomography
Beta methyl iodophenyl pentadecanoic acid

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Heart Diseases
Ischemia
Myocardial Ischemia
Syndrome
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Disease
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014