Known or suspected acute coronary syndrome 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
Sponsors
Synektik Spólka Akcyjna
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Life expectancy 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Primary Objective is to verify if value of summed stress score (SSS) determined in [11C]-DMDPA PET-CT myocardial perfusion imaging corresponds with the incidence of: cardiac death or any severity myocardial infarction or need for revascularization as per physician’s judgment, during the observation period, i.e. between the Day 1 and the end of the study visit, in patients after acute coronary syndrome (ACS) meeting the European Society of Cardiology (ESC) definition and qualified for PET-CT examination.;Secondary Objective: To demonstrate correlation of degree of myocardial ischemia in PET-CT myocardial perfusion imaging (MPI) in patients after ACS with i.e. 1)cardiac hospitalizations 2)angina onset or worsening 3) the quality of life of the patients, 4)functional capacity change 5)their physical functioning, To evaluate impact of PET-CT-MPI results on physician’s assessment of need of revascularization shortly before PET-CT-MPI, and after the receipt of the PET-CT-MPI results, and to assess correlation of the revascularization need assessments pre- and post-PET-CT-MPI with combined incidence of– actually performed revascularization OR clinically significant cardiac event which could have been avoided if the revascularization was performed (as per Investigator’s opinion), and to verify accordance of physician’s assessment of need of revascularization before, and after the PET-CT-MPI, and during, and end of the study.;Primary end point(s): Correlation of incidence of: cardiac death or any severity myocardial infarction or need for revascularization as per physician’s judgment with value of summed stress score (SSS) (as determined with the study PET-CT-MPI), which occurred during the period between Day 1 and the end of the study visit in patients after acute coronary syndrome (ACS) meeting the European Society of Cardiology (ESC) definition and qualified for PET-CT examination.;Timepoint(s) of evaluation of this end point: Period between Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Correlation of degree of myocardial ischemia (SSS, SDS, TPD, CFC, stress MBF, MFR, MBFstress = 2.5 ml/g/min) in PET-CT myocardial perfusion imaging (MPI) with any occurrence of cardiac hospitalizations (including cases when hospitalization is deemed necessary but is not possible) due to exacerbation or onset of new conditions /symptoms (other than related to the previous ACS) excluding short-term hospitalization required to perform diagnostics. 2) Correlation of degree of myocardial ischemia (SSS, SDS, TPD, CFC, stress MBF, MFR, MBFstress = 2.5 ml/g/min) in PET-CT myocardial perfusion imaging (MPI) with occurrence of diagnosis of angina, CCS classification: class II or higher or worsening of existing angina by at least one class. 3) Correlation of degree of myocardial ischemia (SSS, SDS, TPD, CFC, stress MBF, MFR, MBFstress = 2.5 ml/g/min) in PET-CT myocardial perfusion imaging (MPI) with change in the quality of life (assessed with the questionnaire THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF). 4) Correlation of degree of myocardial ischemia (SSS, SDS, TPD, CFC, stress MBF, MFR, MBFstress = 2.5 ml/g/min) in PET-CT myocardial perfusion imaging (MPI) with reduction of the functional capacity below 70% (Functional Capacity Scale). 5) Correlation of degree of myocardial ischemia (SSS, SDS, TPD, CFC, stress MBF, MFR, MBFstress = 2.5 ml/g/min) in PET-CT myocardial perfusion imaging (MPI) with reduction of the physical functioning scale of the questionnaire SF36v.2 (Polish language version). 6) Correlation of degree of myocardial ischemia (SSS, SDS, TPD, CFC, stress MBF, MFR, MBFstress = 2.5 ml/g/min) in PET-CT myocardial perfusion imaging (MPI) with incidence of serious arrhythmic events, namely ventricular tachycardia or fibrillation, third degree heart block or asystolea). 7) Correlation of degree of myocardial ischemia (SSS, SDS, TPD, CFC, stress MBF, MFR, MBFstress = 2.5 ml/g/min) in PET-CT myocardial perfusion imag | — |
Countries
Poland
Contacts
Public ContactSynektik Spólka Akcyjna
Joanna Towpik/Synektik Spólka Akcyjna
Outcome results
None listed