E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028596 |
E.1.2 | Term | Myocardial infarction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate if detection of a particular pattern (e.g., persistent vs. non-persistent) of myocardial αvβ3/5 expression by scintigraphy imaging at 3 and 8 weeks after MI can be used to determine the longer-term risk of developing worsening HF. |
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E.2.2 | Secondary objectives of the trial |
To investigate whether αvβ3/5 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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate the relationship between the myocardial αvβ3/5 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)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The principal investigator will notify the accredited METC and the competent authority of the end of the study within a period of 8 weeks. The end of the study is defined as the last patient’s last visit.
In case the study is ended prematurely, the principal investigator will notify the accredited METC and the competent authority within 15 days, including the reasons for the premature termination.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |