1. Myocardial Infarction (hartinfarct)
Conditions
Interventions
Baseline:
Nuclear myocardial perfusion imaging, at rest and stress, using a thallium 201- or technetium 99m-labelled agent and according to the hospital’s routines, to establish the extent of myocar
Sponsors
GE Healthcare Ltd., and its
affiliates
Eligibility
Inclusion criteria
Inclusion criteria: Subjects may be included in the study if they meet all of the following 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 IMP 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 99mTc-NC100692 Injection* * this inclusion criterion will be asked at 3 and 8 weeks post-MI. Inclusion criterion for subjects with a presumed high post-MI likelihood of developing heart failure: 6. The subject has an LVEF of 40% and is NYHA class 1-2.
Exclusion criteria
Exclusion criteria: Subjects must be excluded from participating in this study if they meet any of the following criteria: 1. The subject was previously entered into this study or has participated in any other investigational medicinal product (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 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 or 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 |
|---|---|
| To investigate the relationship between the myocardial (alpha)V(beta)3/5 expression by scintigraphy at 3 weeks, at 8 weeks and the change from 3 to 8 weeks after MI 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 echocardiography variables LVEF, WMA, LVID and MR in the 6-month and 12-month follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the relationship between the myocardial (alpha)V(beta)3/5 expression by scintigraphy at 3 and 8 weeks after MI and the measured echocardiography variables LVEF, WMA, LVID and MR at 3 and 8 weeks. To investigate the relationship between the myocardial (alpha)V(beta)3/5 expression by scintigraphy at 3 weeks, at 8 weeks and the change from 3 to 8 weeks after MI and other indices of post-MI prognosis such as Killip score (only assessed at pre-discharge), New York Heart Association (NYHA) class (assessed at predischarge, 3 weeks, 8 weeks, 6 months and 12 months) and blood levels of NT-proBNP (measured at predischarge, 6 months, 12 months). | — |
Contacts
Public ContactLeonard Hofstra
Dept. of Cardiology University Hospital Maastricht P. Debeyelaan 25
Outcome results
None listed