News | December 31, 2008

Zemiva More Sensitive in Detecting Cardiac Ischemia Study Says

December 31, 2008 – According to results from a Phase 2 clinical study (BP-23), Zemiva, when combined with the standard of care for the diagnostic evaluation of the chest pain patient, improved sensitivity for the detection of cardiac ischemia by more than 50 percent (p

The study showed that Zemiva’s sensitivity was more than 50 percent greater (p

Zemiva is a fatty acid analog also known as 123I-BMIPP or Iodofiltic Acid I 123 that detects cardiac ischemia by revealing abnormalities in the fatty acid metabolism of the heart. Under normal conditions, 70 to 80 percent of the energy for the heart is produced by the metabolism of fatty acids. However, in ischemic conditions where there is a lack of oxygen, fatty acid metabolism is drastically reduced and carbohydrates become the heart’s primary energy source. This shift in metabolic activity persists for some time, and the phenomenon, called ischemic memory, has been shown by Zemiva imaging to persist for at least 30 hours after chest pain has subsided. Zemiva can be imaged using standard nuclear medicine cameras.

The trial enrolled 510 patients over 14 months at 50 hospitals throughout North America. The primary objective was to evaluate the ability of Zemiva to identify myocardial ischemia in patients who present to the emergency department with suspected acute coronary syndrome. The primary endpoint of the trial was to determine the performance (sensitivity and specificity) of Zemiva and the key secondary endpoint was to determine the clinical benefit of the use of Zemiva as a complement to standard of care. The trial met both the primary and key secondary endpoints. Zemiva was well tolerated. There were no serious adverse effects associated with the product and no patients discontinued the product due to adverse events.

These results were consistent for the subset of patients with acute coronary syndrome (ACS). In both cases, sensitivity and negative predictive value was improved while specificity was maintained. In patients with a negative Zemiva scan, there were no hard cardiac events, including myocardial infarctions or death from cardiac causes during the 30-day follow up.

For more information: www.molecularinsight.com

Related Content

VigiLanz and Cincinnati Children's Commercialize Real-Time Acute Kidney Injury Tracking
News | Contrast Media | November 30, 2018
VigiLanz and Cincinnati Children’s Hospital Medical Center recently announced a collaboration that leverages Cincinnati...
Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Contrast Media | September 12, 2018
In February 2018, a workshop was held at the National Institutes of Health (NIH) in Bethesda, Maryland, to explore co
Ligand Establishes Program to Develop Captisol-Enabled, Next-Generation Diagnostic Imaging Contrast Agents
News | Contrast Media | January 19, 2018
Ligand Pharmaceuticals Inc. announced initiation of a program to develop contrast agents with reduced renal toxicity....
FDA Holds MIDAC Meeting on Gadolinium-Based Contrast Agents. Image by Marilyn Fornell
News | Contrast Media | September 07, 2017
The U.S. Food and Drug Administration (FDA) announced it would hold a meeting of the Medical Imaging Drugs Advisory...
European Medicines Agency Issues Update on Gadolinium Contrast Agents
News | Contrast Media | August 29, 2017
August 29, 2017 — The European Medicines Agency (EMA) issued a final opinion that recommended restricting the use of
Guerbet Announces Plans to Streamline Contrast Media Portfolio, gadolinium MRI contrast
News | Contrast Media | July 18, 2017
Guerbet recently announced that it will phase out sales throughout the world of two products: Hexabrix (meglumine and...
ACR Offers Revised Contrast Media in Imaging Manual
News | Contrast Media | July 17, 2017
The American College of Radiology (ACR) recently revised its authoritative guide for the safe and effective use of...
Bayer Arterion contrast Injector used to administer medical imaging contrast for CT scans.

Bayer Healthcare's Arterion contrast injector system.

Feature | Contrast Media | June 19, 2017 | Dave Fornell
Here are several updates in medical imaging...
PRAC, European Medicines Agency, gadolinium-based contrast agents, safety recommendations, brain MRI
News | Contrast Media | March 13, 2017
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recently released new...
Lantheus Medical Imaging, Definity, FDA approval, label update, echocardiography, cardiac shunt contraindication
Technology | Contrast Media | February 02, 2017
Lantheus Medical Imaging Inc. announced U.S. Food and Drug Administration (FDA) approval of a label update for Definity...
Overlay Init