Accuracy of Radiolabeled Fatty Acid Analog, BMIPP, in the Late Detection of Decreased Blood Flow to the Heart - Full Text View

Purpose

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 ACS. To 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 II

MedlinePlus related topics:

Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stratum A: Active Comparator 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.
Stratum B: Active Comparator 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.
Stratum C: Active Comparator 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585663

Contacts


Contact: Raymond R Russell, MD, PhD	203-785-2241	raymond.russell@yale.edu

Contact: Janice E Davey, RN	203-688-6482	janice.davey@yale.edu

Locations


United States, Connecticut
	Yale-New Haven Hospital	Recruiting
	New Haven, Connecticut, United States, 06510
	Contact: Raymond R Russell, MD, PhD 203-785-2241 raymond.russell@yale.edu
	Principal Investigator: Raymond R Russell, MD, PhD

Sponsors and Collaborators

Yale University

Molecular Insight Pharmaceuticals, Inc.

Investigators


Study Director:	Norman LaFrance, MD	Molecular Insight Pharmaceuticals, Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

Knapp FF Jr, Kropp J. Iodine-123-labelled fatty acids for myocardial single-photon emission tomography: current status and future perspectives. Eur J Nucl Med. 1995 Apr;22(4):361-81. Review.

Morimoto K, Tomoda H, Yoshitake M, Aoki N, Handa S, Suzuki Y. Prediction of coronary artery lesions in unstable angina by iodine 123 beta-methyl iodophenyl pentadecanoic acid (BMIPP), a fatty acid analogue, single photon emission computed tomography at rest. Angiology. 1999 Aug;50(8):639-48.

Dilsizian V, Bateman TM, Bergmann SR, Des Prez R, Magram MY, Goodbody AE, Babich JW, Udelson JE. Metabolic imaging with beta-methyl-p-[(123)I]-iodophenyl-pentadecanoic acid identifies ischemic memory after demand ischemia. Circulation. 2005 Oct 4;112(14):2169-74. Epub 2005 Sep 26.

Responsible Party:	Molecular Insights Pharmaceuticals ( Normal LaFrance, MD/Chief Medical Officer )
Study ID Numbers:	BMIPP, MIP-BP23
First Received:	December 25, 2007
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00585663
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

Study placed in the following topic categories:

Arterial Occlusive Diseases

Coronary Disease

Heart Diseases

Myocardial Ischemia

Acute Coronary Syndrome

Vascular Diseases

Arteriosclerosis

Ischemia

Coronary Artery Disease

Additional relevant MeSH terms:

Disease

Pathologic Processes

Syndrome

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 28, 2008

Sponsors and Collaborators:	Yale University Molecular Insight Pharmaceuticals, Inc.
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00585663