Myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10028596 Term: Myocardial infarction
Conditions
Interventions
Trade Name: Telmisartan
Product Name: Telmisartan
Product Code: 144701-48-4
Pharmaceutical Form: Tablet
INN or Proposed INN: TELMISARTAN
CAS Number: 144701484
Concentration unit: mg milligram(s)
Conce
Sponsors
MUMC+
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The subject has had no previous MI, presents with acute MI and has undergone coronary angiography during which percutaneous coronary intervention (PCI) or no intervention may be performed. (2) The subject is =18 years of age at study entry. (3) The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained, including permission to access coronary angiography records (see inclusion criterion No. 1), before any study procedure is carried out. (4) The subject is male, or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test performed before administration of 99mTc-NC100692 Injection is negative. (5) The subject has been clinically stable (e.g., not experiencing continuing chest pain or haemodynamic instability) for at least 7 days before each imaging session with 99mTcNC100692 Injection* (6) The subject has an LVEF of =40% and =55% and is NYHA class 1-2. * This inclusion criterion will be checked at 3 and 8 weeks post-MI. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) The subject was previously entered into this study or has participated in any other IMP study within 30 days of study entry. (2) The subject is scheduled to receive another IMP from time of entry into this study until completion of the follow-up period after the second injection proposed for this study. (3) The subject has known allergies to any product used in this study or its constituents (e.g., para-amino benzoic acid). (4) The subject undergoes monitoring of occupational radiation exposure. (5) The subject presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 12 months, where participation in the study might compromise the management of the subject, or for any other reason that in the judgement of the investigator(s) makes the subject unsuitable for participation of the study. (6) The subject is scheduled to have a revascularisation procedure (e.g., PCI or CABG) or cardiac transplant in the 30 days after study entry. (7) The subject participated in a research study using ionising radiation within 12 months of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if detection of a particular pattern (e.g., persistent vs. non-persistent) of myocardial avß3/5 expression by scintigraphy imaging at 3 and 8 weeks after MI can be used to determine the longer-term risk of developing worsening HF. ;Secondary Objective: To investigate whether avß3/5 imaging can be used as a surrogate endpoint for the outcome of therapeutic interventions, using standard and novel treatments (ACE-I vs. ACE-I+ARB vs. ACE-I+Renin inhibitor).;Primary end point(s): To investigate the relationship between the myocardial avß3/5 expression by scintigraphy at 3 and 8 weeks after MI, and the change from 3 to 8 weeks, and signs of a poor post-MI prognosis based on occurrence of MACE and/or signs of developing HF evident from worsening in the measured CMRI variables in the 12-month follow-up period. A patient is presumed HF positive during the study (i.e., at the 12 months follow-up visits) if he/she fulfils any of the following criteria: • decrease in LVEF of at least 5% • increase in LVID of 5 mm • worsening in WMA, i.e., increase in score of at least 3 segments • worsening in MR, i.e., worsening of category • occurrence of MACE • worsening in NYHA class (from I or II to III or IV, or from III to IV) | — |
Countries
Netherlands
Outcome results
None listed