A Phase III Study of [11C]-DMDPA Tracer for Positron Emission Tomography PET-CT Myocardial Perfusion Imaging (MPI).

Phase 1

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

• Registration Number: EUCTR2021-002557-29-PL
• Lead Sponsor: Synektik Spólka Akcyjna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-15
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1.Male and female subjects at least 18 years of age at the moment of start of the screening
2.At the time of first dosing of the study product in the study the subject is at the earliest 30 days after onset of acute coronary syndrome (ACS) which met the ECS definition of ACS,
3.The subject is able to understand the study concept and provide written consent to it, and has agreed to participate in the study, read, signed and dated the informed consent form (ICF) prior to any study procedures being performed,
4.The subject is able and willing to comply with all study procedures as described in the protocol.
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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion Criteria

1.Life expectancy < 1 year.
2.BMI=32.5
3.Active or with high risk of recurrence, as per Investigator’s judgment, oncological condition except for basal cell skin cancer.
4.Subject exposed to radiation >6mSv within 12 months prior to the study PET-CT imaging or known or expected need for >6mSV radiation-involving procedures or exposures other than the study PET-CT.
5.Known cardiovascular medical history and conditions or past or future procedures deemed particularly important from the study perspective:
•Past results of left ventricular ejection fraction (LVEF) <40%
•Past, current, or planned cardiac surgical treatment including e.g. coronary angioplasty, stents, by-pass, during the participation in the study
• Three or more ACS episodes in the past
•Known at the time of screening, planned, early revascularization
•Poorly controlled hypertension with blood pressure over 180/100 mmHg despite medications, during period between ACS and Screening to this study
•Systolic blood pressure below 100 mmHg measured shortly before PET-CT MPI
•Acute, clinically relevant changes in electrocardiogram (ECG) in comparison to the most recent ECG
•NYHA Class III or IV Congestive heart failure
•known non-ischemic cardiomyopathy or significant valvular heart disease as judged by the investigator
•symptomatic hypotension as per Investigator’s judgment
•severe or otherwise clinically significant cardiac arrhytmias including atrial fibrillation, which could significantly influence risk of major cardiac events regardless of myocardial perfusion’s quality, as per Investigator’s judgment
•other cardiovascular condition which is an absolute contraindication to the PET-CT-MPI procedure
•diagnosed carotid artery stenosis 60% or higher
•recent or unresolved myocarditis
•ischemic stroke in the past (except for TIA or small-size strokes which occurred >10 years ago and recovered leaving no neurologic deficit),
•pulmonary embolism within last 5 years
•long QT syndrome or QTcB>470 in males and >480 ms in females
•recent myocardial infarction in the context of precautions for regadenoson administration, per Investigator’s judgment
6. History of seizures or other risk factors for seizures, including the concomitant administration of medicinal products that lower seizure threshold in the context of precautions for regadenoson administration, per Investigator’s judgment.
7. Inability to lie still for the test.
8. Smoking equivalent of 10 or more cigarettes/day.
9. Need for anticoagulant treatment except for prophylactic doses of ASA as judged by the investigator.
10. Active severe inflammatory condition as judged by the Investigator.
11. Permanent use of systemic corticosteroids with dose equivalent to >10mg/day of prednisone.
12. Need for regular use of strong immunosuppressive medications (e.g. cyclosporine, methotrexate etc.) or chemotherapy, as judged by the investigator.
13. Past, recent or current daily use of medications with known strong cardiotoxic side effects as judged by the investigator.
14. Conditions which involve bronchospasm
15. Diabetes type 1 or another type of diabetes requiring use of insulin.
16. Serum creatinine > 2 mg/dL.
17. Anemia, grade II or worse (according to CTCAE v.5.0 classification).
18. Any exposure to any investigational product(s), drug(s) or medical device(s) within four weeks prior to the study imaging procedure.
19.Any clinically significant, acute or unstable physical, psychiatric or psychological disease/condition
20.Aller

Study & Design

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