Phase II: 68Ga-NODAGA-E[c(RGDyK)]2 Angiogenese PET for imaging angiogenesis in ST-Elevation Myocardial Infarction(STEMI)

Phase 1

• Conditions: ST-Elevation Myocardial Infarction (STEMI); MedDRA version: 20.0Level: LLTClassification code 10019250Term: Heart attackSystem Organ Class: 100000011654; MedDRA version: 20.0Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000011652; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2017-002709-36-DK
• Lead Sponsor: Rigshospitalet, Department of Physiology, Nuclear Medicine and PET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-07
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The inclusion criteria are patients diagnosed with ST-Elevation Myocardial Infarction (STEMI), treated with Percutaneous Coronary Intervention (PCI). 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 with prior STEMI
2. Patient who prior underwent cardiac surgery
3. Patient recieving anti-angiogenetick treatmen
4. Patient with known allergi towards interveneous contrast
5. Patient with pacemaker, cochlear implant or insulinpump
6. Pregnancy
7. Lactation
8. Obesity (weight above 140 kg)
9. Claustrophobia

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 after an heartattack. 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 PCI ;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 three different days:<br>1. Scan: 1-3 days after PCI<br>2. Scan: 7-10 days after PCI<br>3. Scab: 30-35 days after PCI

Secondary Outcome Measures

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