In vivo molecular imaging of angiogenesis after VEGF-D gene therapy

Phase 1

• Conditions: Ischemic heart disease; MedDRA version: 20.0Level: LLTClassification code 10023024Term: Ischaemic heart diseaseSystem Organ Class: 100000004849; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2018-001494-24-DK
• Lead Sponsor: Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-26
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-informed consent signed
-age > 30 but < 85 years
-significant angina pectoris (CCS 2-3) despite of optimal medication
-significant stenosis (> 60%) in coronary angiography (< 12 months)
-contraindication to CABG or PCI due to diffuse or distal stenosis, chronic total occlusion, vessels with difficult anatomy, stenosis with severe calcifications and stenosis in small vessels (<2.5 mm)
-angina pectoris or equivalent symptoms in the 6-minute walking exercise test
-left ventricle wall > 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

-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 < 120 mg/l in male, < 110 mg/l in female; hematocrit < 0.36)
-leukopenia (b-leukocyte count < 3.0x109/l), leukocytosis (b-leukocyte count > 12.0x109/l) or thrombocytopenia (b-thrombocyte count < 100x109/l)
-renal insufficiency (P-creatinine > 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 < 90 mmHg)
-significant obesity (BMI > 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Association between degree of myocardial angiogenesis and clinical effect of VEGF-D therapy.<br>2. Association between degree of myocardial angiogenesis and improvement in myocardial perfusion following VEGF-D therapy.<br>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