Phase II: 68Ga-NODAGA-E[c(RGDyK)]2 Angiogenese PET for imaging angiogenesis in ischaemic heart disease

Phase 1

• Conditions: Ischaemic heart disease; MedDRA version: 20.0Level: LLTClassification code 10023024Term: Ischaemic heart diseaseSystem Organ Class: 100000011627; MedDRA version: 20.0Level: LLTClassification code 10008937Term: Chronic ischemic heart disease, unspecifiedSystem Organ Class: 100000011627; MedDRA version: 20.0Level: LLTClassification code 10055218Term: Ischemic heart diseaseSystem Organ Class: 100000011627; MedDRA version: 20.0Level: LLTClassification code 10008936Term: Chronic ischaemic heart disease, unspecifiedSystem Organ Class: 100000011627; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2017-002712-14-DK
• Lead Sponsor: Rigshospitalet, Department of Physiology, Nuclear Medicine and PET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-06
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: non applicable;Primary end point(s): To evaluate myocardial angiogenesis using 68Ga-NODAGA-E-[RGDyK]2 after intervention;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:<br>1. Scan: 14-21 days prior intervention<br>2. Scan: 30-35 days after intervention<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and change in myocardial perfusion after intervention<br>- Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and functional recovery 30 days after intervention<br>- Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and viability before and after intervention;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.