A prospective cohort study to investigate the use of alfa V beta 3 integrin scintigraphic imaging with 99mTC-NC100692 to predict scar formation and heart failure after myocardial infarction in patients. - ANG692

MUMC+0 sitesFebruary 17, 2009

Overview

No summary available.

Registry

who.int

Start Date

February 17, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

MUMC+

•(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

•(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.