E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute or chronic coronary artery occlusion |
Akuutti tai krooninen sepelvaltimon tukos |
|
E.1.1.1 | Medical condition in easily understood language |
Coronary artery disease associated with an acute or chronic occlusion of a coronary artery |
Sepelvaltimotauti, jossa sepelvaltimo on tukkeutunut äkillisesti tai pitkän ajan kuluessa |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
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 |
Evaluate PET imaging with 68Ga-NODAGA-RGD in patients with acute or chronic coronary artery occlusion |
Tutkia PET kuvantamista 68Ga-NODAGA-RGD -merkkiaineella potilailla, joilla on akuutti tai krooninen sepelvaltimon tukos |
|
E.2.2 | Secondary objectives of the trial |
Study relationship between 68Ga-NODAGA-RGD uptake and contractile function of the myocardium supplied by occluded coronary artery |
Verrata 68Ga-NODAGA-RGD -merkkiaineen kertymää tukkeutuneen sepelvaltimon suonittaman sydänlihaksen toimintaan |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Acute ST-elevation myocardial infarction within 3-14 days or planned percutaneous intervention of chronic coronary artery occlusion within 4 weeks |
Akuutti sydäninfarkti, johon liitty ST-nousu sydänsähkökäyrässä 3-14 päivän aikana tai suunniteltu kroonisen sepelvaltimon tukoksen pallolaajennustoimenpide 4 viikon aikana |
|
E.4 | Principal exclusion criteria |
Age <18 or ≥ 85 years, current unstable angina pectoris, significant valvular heart disease, NYHA IV heart failure symptoms, severe untreated hypertension (>180/110 mmHg), female not post-menopausal, severe renal failure (GFR < 30 ml/min), severe tachyarrhythmias, previous cardiac surgery
|
Ikä <18 or ≥ 85 vuotta, epästabiili rintakipuoire, merkittävä sydämen läppävika, NYHA IV sydämen vajaatoimintaoire, vaikea hoitamaton verenpainetauti (>180/110 mmHg), fertiili-ikäinen nainen, vaikea munuaisten vajaatoiminta (GFR <30ml/min), aiempi avosydänleikkaus |
|
E.5 End points |
E.5.1 | Primary end point(s) |
68Ga-NODAGA-RGD tracer uptake in PET images in the myocardium supplied by an occluded coronary artery |
PET kuvauksessa mitattu 68Ga-NODAGA-RGD -merkkiaineen kertymä tukkeutuneen sepelvaltimon suonittamassa sydänlihaksessa |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 to 14 days after acute coronary artery occlusion or within 4 weeks before and 2 weeks after planned percutaneous intervention of chronic coronary occlusion |
3-14 päivää akuutin sepelvaltimotukoksen jälkeen tai enintään 4 viikkoa ennen suunniteltua kroonisen sepelvaltimon tukoksen pallolaajennustoimenpidettä ja uudelleen 2 viikkoa toimenpiteen jälkeen |
|
E.5.2 | Secondary end point(s) |
Regional myocardial contractile function assessed by echocardiography |
Sydänlihaksen alueellinen supistuminen ultraäänitutkimuksessa |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the time of PET imaging with 68Ga-NODAGA-RGD and 6 months after PET with 68Ga-NODAGA-RGD |
68Ga-NODAGA-RGD PET kuvauksen yhteydessä ja sekä 6 kuukautta 68Ga-NODAGA-RGD PET kuvauksen jälkeen |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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) | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
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
|
The last visit of the last subject |
Viimsisen tutkittavan viimeinen käynti |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |