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Iodofiltic acid I 123 · 1 trial · 1 indication
Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.
| Arm | Type | Description |
|---|---|---|
| Iodofiltic Acid I 123 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Iodofiltic acid I 123 | DRUG | - |
Inclusion Criteria: * Provide written informed consent and are willing to comply with protocol requirements * Are 40 years of age or older. * Are being evaluated for possible ACS. * If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy tes...
Iodofiltic acid I 123 is an investigational small molecule being studied for use in Acute Coronary Syndrome (ACS). It is a radiolabeled fatty acid analog that is being evaluated for its safety and efficacy in patients with ACS. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Iodofiltic acid I 123 is a radiolabeled fatty acid analog. It is designed to be taken up by myocardial cells, where it can be used to assess cardiac metabolism and perfusion. This mechanism is being investigated for its potential to aid in the diagnosis and management of Acute Coronary Syndrome.
Iodofiltic acid I 123 is being developed by Insight Molecular Diagnostics Inc., a company traded under the ticker symbol IMDX. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Acute Coronary Syndrome.
Iodofiltic acid I 123 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its potential use in Acute Coronary Syndrome, and its safety and efficacy are still being evaluated in clinical trials.
Iodofiltic acid I 123 has been studied in one completed Phase 2 clinical trial, identified as NCT00514501. This trial, titled 'Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome,' enrolled 510 participants across the United States and Canada. The study was uncontrolled and did not use randomization or blinding.