Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. The resulting independent reading of the images will be compared against the truth standard for ACS.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodofiltic Acid I 123 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodofiltic acid I 123 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) | 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. | Day 30 |
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) | 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. | Day 30 |
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Norman LaFrance, MD | Molecular Insight Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20633821 | Derived | Kontos MC, Dilsizian V, Weiland F, DePuey G, Mahmarian JJ, Iskandrian AE, Bateman TM, Heller GV, Ananthasubramaniam K, Li Y, Goldman JL, Armor T, Kacena KA, LaFrance ND, Garcia EV, Babich JW, Udelson JE. Iodofiltic acid I 123 (BMIPP) fatty acid imaging improves initial diagnosis in emergency department patients with suspected acute coronary syndromes: a multicenter trial. J Am Coll Cardiol. 2010 Jul 20;56(4):290-9. doi: 10.1016/j.jacc.2010.03.045. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Iodofiltic Acid I 123 | A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 30 |
| Huntsville |
| Alabama |
| United States |
| Mesa | Arizona | United States |
| Los Angeles | California | United States |
| Mission Viejo | California | United States |
| Newport Beach | California | United States |
| Roseville | California | 95661 | United States |
| Hartford | Connecticut | United States |
| New Haven | Connecticut | United States |
| Newark | Delaware | United States |
| Jacksonville | Florida | United States |
| Aurora | Illinois | United States |
| Maywood | Illinois | United States |
| Louisville | Kentucky | 40207 | United States |
| Auburn | Maine | United States |
| Bethesda | Maryland | United States |
| Detroit | Michigan | United States |
| Royal Oak | Michigan | United States |
| Troy | Michigan | 48085 | United States |
| Minneapolis | Minnesota | United States |
| Kansas City | Missouri | 64111 | United States |
| Lebanon | New Hampshire | United States |
| Manchester | New Hampshire | United States |
| Albany | New York | United States |
| Brooklyn | New York | United States |
| Kingston | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Syracuse | New York | 13210 | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Providence | Rhode Island | United States |
| Houston | Texas | United States |
| Richmond | Virginia | United States |
| Madison | Wisconsin | United States |
| North Vancouver | British Columbia | Canada |
| Scarborough Village | Ontario | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Iodofiltic Acid I 123 | A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) | 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. | The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation. | Posted | Number | 95% Confidence Interval | % (n/N) | Day 30 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) | 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. | The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation. | Posted | Number | 95% Confidence Interval | % (n/N) | Day 30 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) | 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. | The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation. | Posted | Number | 95% Confidence Interval | % (n/N) | Day 30 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iodofiltic Acid I 123 | A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose. | 28 | 507 | 32 | 507 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure, acute | Cardiac disorders |
| |||
| Cardiac arrest | Cardiac disorders |
| |||
| Ventricular fibrillation | Cardiac disorders |
| |||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Mental status changes | Nervous system disorders |
| |||
| Chest pain | Cardiac disorders |
| |||
| Myocardial infarction | Cardiac disorders |
| |||
| Renal failure | Renal and urinary disorders |
| |||
| Arterial injury | Injury, poisoning and procedural complications |
| |||
| Unstable angina | Cardiac disorders |
| |||
| Aortic dissection | Cardiac disorders |
| |||
| Hematoma | Vascular disorders |
| |||
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
| |||
| Gastroesophageal reflux disease | Gastrointestinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Communications | Progenics Pharmaceuticals, Inc. | 914 784-1825 | vdipippo@progenics.com |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C049338 | iodofiltic acid |
Not provided
Not provided
Not provided
| Participants |
|
|
| Participants |
|
|