Evaluation of [11C] DMDPA product during coronary artery disease diagnostic with positron emission tomography (PET)

Phase 1

Active, not recruiting

• Conditions: known or suspected coronary artery disease; MedDRA version: 20.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002055-28-PL
• Lead Sponsor: Synektik Spólka Akcyjna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-23
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified