Acute Coronary Syndrome
Conditions
Brief summary
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.
Interventions
DRUGIodofiltic acid I 123
Sponsors
Molecular Insight Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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 test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.
Exclusion criteria
* \<40 years of age. * 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 x-ray contrast media or iodine/iodides. * Currently or formerly on medication that targets fatty acid uptake or metabolism, eg 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) | Day 30 | 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. |
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) | Day 30 | 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. |
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) | Day 30 | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 507 |
| Total | 507 |
Baseline characteristics
| Characteristic | Iodofiltic Acid I 123 |
|---|---|
| Age, Continuous | 59.2 years |
| Sex: Female, Male Female | 232 Participants |
| Sex: Female, Male Male | 275 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 507 |
| serious Total, serious adverse events | 28 / 507 |
Outcome results
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.
Time frame: Day 30
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iodofiltic Acid I 123 | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) | Sensitivity | 75.2 % (n/N) |
| Iodofiltic Acid I 123 | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) | Specificity | 67.7 % (n/N) |
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.
Time frame: Day 30
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iodofiltic Acid I 123 | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) | Sensitivity | 75.2 % (n/N) |
| Iodofiltic Acid I 123 | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) | Specificity | 59.8 % (n/N) |
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.
Time frame: Day 30
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iodofiltic Acid I 123 | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) | Sensitivity | 74.3 % (n/N) |
| Iodofiltic Acid I 123 | Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) | Specificity | 71.6 % (n/N) |