E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023024 |
E.1.2 | Term | Ischaemic heart disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008937 |
E.1.2 | Term | Chronic ischemic heart disease, unspecified |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055218 |
E.1.2 | Term | Ischemic heart disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008936 |
E.1.2 | Term | Chronic ischaemic heart disease, unspecified |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 |
The primary objective of the study is to test a new radio tracer called 68Ga-NODAGA-E-[RGDyK]2 for PET imaging of angiogenesis. The tracer has the potential of identifying heart tissue with a high level of angiogenesis. Angiogenesis is a very important factor in reparing heart tissue. Therefor, the tracer can potentially be used to asses how the tissue respons to the chosen therapy. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The inclusion criteria are patients diagnosed with chronic occlusion of the coronary being treated with Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft(CABG) operation. The patients must be above the age of 18 years, and must be capable of understanding and giving full informed written consent. |
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E.4 | Principal exclusion criteria |
The principal exclusion criteria are:
1. Patient who prior underwent cardiac surgery
2. Patient recieving anti-angiogenetick treatment
3. Patient with known allergi towards interveneous contrast
4. Patient with pacemaker, cochlear implant or insulinpump
5. Pregnancy
6. Lactation
7. Obesity (weight above 140 kg)
8. Claustrophobia
9. Re-operation after intervention
10. Conversion to open surgery during intervention |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate myocardial angiogenesis using 68Ga-NODAGA-E-[RGDyK]2 after intervention |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The patient will be PET scanned after injection af the radio tracer 68Ga-NODAGA-E-[RGDyK]2. The patient will be scanned on two different days:
1. Scan: 14-21 days prior intervention
2. Scan: 30-35 days after intervention
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E.5.2 | Secondary end point(s) |
- Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and change in myocardial perfusion after intervention
- Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and functional recovery 30 days after intervention
- Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and viability before and after intervention |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 in the Heart will be assessed by PET scans after injection. |
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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 | Yes |
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) | 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 | 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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
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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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |