known or suspected coronary artery disease MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Code: [11C]-DMDPA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [11C] dimethyl diphenyl ammonium chloride ([11C]-DMDPA)
Current Sponsor code: [11C] DMDPA
Other descriptive
Sponsors
Synektik Spólka Akcyjna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects over 18 years of age with known (proven myocardial infarction or one or more significant narrowing in coronary angiography) or suspected CAD having given informed consent referred for MPI for diagnosis and/or risk stratification for CAD or Patients after ICA without PCI within 60 days. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination; Blood pressure over 180/100 mmHg or below 100 mmHg systolic Acute changes in comparison to most recent electrocardiogram (ECG); Recent (within 3 months) cardiac arrest, unstable angina, cerebro vascular accident (CVA), coronary artery bypass grafting (CABG) or PCI Any pacemaker or defibrillator implanted within the last three months; Inability to remain in camera for approximately 15 minutes Bronchospasm Serum creatinine > 2 mg/dL; Cancer patients who have received chemotherapy or radiation therapy or antiangiogenic within the past 60 days. Any exposure to any investigational drug(s) or medical device(s) within four weeks prior to imaging study; Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination. NYHA Class III or IV Congestive heart failure; Subject has symptomatic hypotension Allergic or intolerant to theophylline, nitroglycerin or metoprolol Female subjects only: Positive serum and/or urine pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing. Females of child-bearing potential (defined as all females after puberty who are not postmenopausal for at least 1 year, or who undergo hysterectomy or who are surgically sterile e.g. after ovariectomy or bilateral tubal ligation) require confirmatory documentation in their medical records and must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days before V1 and at least 30 days following [11C]-DMDPA injection; Adequate contraceptive measures include: oral contraceptives, contraceptive injections or implants, hormone patches (stable use for 1 or more cycles before V1); intrauterine device; condom or diaphragm with spermicide; or sexual abstinence. Contraceptive methods that are not adequate and not acceptable during the study are: periodic sexual abstinence assessed based on e.g. ovulation calendar, fertility days by monitoring of temperature and / or symptom observation (cervical mucus, mood changes); Sexually active female of child bearing potential must agree to use two adequate contraceptive methods e.g. condom and oral contraceptive. Note: it is not acceptable to use condom and diaphragm simultaneously because during sexual act the devices can be damaged and do not prevent pregnancy. Nursing mothers Male subjects would require reliable contraception method from the first injection with the tracer until 100 days after the last injection with the tracer. The following contraceptive method(s) is (are) allowed during the study: Condom or sexual abstinence. If the partner becomes pregnant during the study, the participant should immediately report this to the investigator. Presence of absolute contraindications to the procedure hypersensitivity to the radiopharmaceutical second degree A-V block in the patient without cardiostimulator inability to lie still for the duration of the acquisition claustrophobia Presence of relative contraindications to the procedure Xanthine derivatives (caffeine, theophylline, and theobromine containing foods and beverages, and theophylline, caffeinecontaining medications) within 12 hours before the imaging (s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety of [11C] DMDPA used as PET imaging agent for evaluation of myocardial perfusion in subjects with known or suspected CAD. To optimize the [11C] DMDPA dose used for PET evaluation of myocardial perfusion in subjects with known or suspected CAD at vasodilatation stress and at rest. ;Secondary Objective: To optimize the imaging parameters for dynamic and static acquisitions. To evaluate diagnostic ability to detect fixed and reversible perfusion abnormalities. To define its ability to measure myocardial perfusion with regard to image quality, certainty of interpretation, and feasibility of measurement. To define its ability to measure myocardial perfusion with regard to interpretation confidence in patients with suspected or proven CAD. ;Primary end point(s): 1.Safety: the number and proportion of related adverse events (AEs) per study (dose) arm; 2.Dose finding: the number and proportion of patients in whom calculated perfusion is within 0.5 5 mL/g tissue/minute per study (dose) arm. ;Timepoint(s) of evaluation of this end point: 1.V1, V2, V3, V4 2.Randomization (V1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.To assess sensitivity and specificity for each [11C] DMDPA dose arm for the detection of perfusion disturbances. 2.To assess the number and proportion of patients with interpretable images per study (dose) arm as assessed by blinded evaluators. 3.To compare baseline (pre-injection) values to post-injection values for: • Laboratory testing which includes hematology, serum chemistry, urine analysis, and cardiovascular markers • Electrocardiograms, Serial QT and QTc measurements • Physical Examinations • Vital signs which includes heart rate, and systolic and diastolic blood pressure • AE Assessments ;Timepoint(s) of evaluation of this end point: 1.Randomization (V1) 2.Randomization (V1) 3.a)Randomization (V1) versus V2 b) V0,V1, V2, V3, V4 c) V0,V1, V2, V3, V4 d) V0,V1, V2, V3, V4 e) V0,V1, V2, V3, V4 | — |
Countries
Poland
Contacts
Public ContactCRO company
ClinMed Pharma Sp. z o.o.
Outcome results
None listed