Observational study; An open-label, phase 2a imaging study to assess the utility off 99mTc-NC100692 injection in post-MI patients to predict risk of developing chronic heart failure.
Completed
- Conditions
- <br />2. Heart Failure (hartfalen).1. Myocardial Infarction (hartinfarct)
- Registration Number
- NL-OMON22503
- Lead Sponsor
- GE Healthcare Ltd., and itsaffiliates
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.<br /><br /><br>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).