Overview
Sponsor-declared trial summary
Chronic ischemic heart disease
Investigate and characterize the difference in myocardial angiogenesis measured with RGD-PET uptake before and after coronary revascularization in patients with chronic ischemic heart disease.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Phenomena and Processes [G] - Cell Physiological Phenomena [G04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Decision date (initial)
- 2025-01-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518640-20-00
- EudraCT number
- 2017-002712-14
- ClinicalTrials.gov
- NCT03505346
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Investigate and characterize the difference in myocardial angiogenesis measured with RGD-PET uptake before and after coronary revascularization in patients with chronic ischemic heart disease.
Conditions and MedDRA coding
Chronic ischemic heart disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Subjects > 50 years old
- Subjects admitted to the Heart Center, Rigshospitalet, with chronic occlusion of coronary arteries and clinically referred for either PCI or CABG.
Exclusion criteria 12
- Subject with a history of heart surgery
- Subject receiving strong anti-angiogenic medication such as Avastin ©
- Pregnancy
- Lactation
- Severe claustrophobia to a degree that makes PET/CT scanning impossible
- Severe obesity (>140 kg)
- Re-operation during intervention
- Conversion from PCI to open surgery
- If the subject is of childbearing age, a pregnancy test will be performed prior to the injection of the tracer. If positive, the patient will be excluded from the study
- If the subject shows clinical signs of a severe allergic reaction related to intravenous contrast agent or the tracer, the patient will be withdrawn from the study
- If it is discovered during the PET scan that the tracer has been injected subcutaneously, the subject will be withdrawn from the project
- Uncontrolled diabetes type I & II (HbA1c >70)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Characterize the difference in myocardial angiogenesis measured with RGD-PET uptake before and after coronary revascularization
Secondary endpoints 3
- Correlation between myocardial angiogenic response (determined by RGD-PET) and changes in myocardial perfusion (82Rb-PET) after coronary revascularization.
- Correlation between myocardial angiogenic response after 3 weeks (determined by RGD-PET) and functional recovery and final infarct (18F-FDG-PET) size 6-8 weeks after coronary revascularization
- Correlation between myocardial angiogenic response (determined by RGD-PET) and viability (18-F-FDG) before and after coronary revascularization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11777423 · Product
- Active substance
- [68GANODAGA-GLUCYCLO-ARG-GLY-ASP-D-TYR-LYS2
- Substance synonyms
- [68Ga]NODAGA-E[c(RGDyK)]2
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 300 MBq megabecquerel(s)
- Max total dose
- 600 MBq megabecquerel(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- REGION HOVEDSTADENS APOTEK
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Johanne Madsen
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Johanne Madsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 42 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 68 Ga-NODAGA-E[c(RGDyK)]2 Angiogenese PET for imaging angiogenesis in ischemic heart disease | 7 |
| Recruitment arrangements (for publication) | 24-12-11-Recruitment-arrangements_PH-2024-518640-20-00_RGD | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation_iskmi_CABG_vers_7_24_10_2024 | 7 |
| Subject information and informed consent form (for publication) | Deltagerinformation_iskmi_PCI_vers_7_24_10_2024 | 7 |
| Subject information and informed consent form (for publication) | informationssamtykke_version2_14_5_2020 | 2 |
| Synopsis of the protocol (for publication) | Protokolsynopsis_Iskmi_vers_6_24_10_2024 | 6 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-29 | Denmark | Acceptable 2024-12-16
|
2025-01-08 |