Ischemic heart disease MedDRA version: 20.0 Level: LLT Classification code 10023024 Term: Ischaemic heart disease System Organ Class: 100000004849
Conditions
Interventions
Product Name: 68Ga-NODAGA-E[c(RGDyK)]2
Product Code: 68Ga-NODAGA-E[c(RGDyK)]2
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: 68GA-NODAGA-e[c(RGDyK)]2
Curr
Sponsors
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - informed consent signed - age > 30 but 60%) in coronary angiography ( 8 mm detected by transthoracic echocardiography (treatment area) 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - women in fertile age - diabetes mellitus with severe complications such as proliferative diabetic retinopathy or nephropathy with renal insufficiency (see below) - clinically significant anemia (hemoglobin count 12.0x109/l) or thrombocytopenia (b-thrombocyte count 160 mg/l) - liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal) - hematuria of unknown origin - severe hypertension (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg) or significant hypotension (systolic blood pressure 35) - acute infection - immunosuppressive medication - significant impairment of left ventricular function (EF < 25%) - symptomatic congestive heart failure (NYHA 3-4) - hemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery - recent (< 3 months) acute coronary syndrome or myocardial infarction (elevated CK-MB or cardiac troponin), PCI, CABG or TIA/stroke - current or suspected malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To use 68Ga-NODAGA-E[c(RGDyK)]2 PET/CT scans as a tool to image myocardial angiogenesis;Secondary Objective: Not applicable;Primary end point(s): Change in myocardial angiogenesis following treatment with VEGF-D therapy compared to placebo;Timepoint(s) of evaluation of this end point: 6 months after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Association between degree of myocardial angiogenesis and clinical effect of VEGF-D therapy. 2. Association between degree of myocardial angiogenesis and improvement in myocardial perfusion following VEGF-D therapy. 3. Association between degree of myocardial angiogenesis and improvement in myocardial function following VEGF-D therapy.;Timepoint(s) of evaluation of this end point: 6 months after inclusion | — |
Countries
Denmark
Contacts
Public ContactRasmus Ripa
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET
Outcome results
None listed