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In vivo molecular imaging of angiogenesis in type 2 diabetes

Phase 1
Active, not recruiting
Conditions
Type 2 diabetes
MedDRA version: 20.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 100000004861
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Registration Number
EUCTR2019-003466-41-DK
Lead Sponsor
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Recruiting
Sex
All
Target Recruitment
90
Inclusion Criteria

•Written informed consent must be provided before participation
•Previous participation in the ”Kardiovaskulær risikoprofil hos personer med og uden type 2 diabetes vurderet med hjerte 82Rb-PET - Projekt-ID H-3-2013-015” study

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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

•Pregnancy or breastfeeding (urine HCG is performed on all fertile women)
•Myocardial infarction = 30 days before inclusion
•Percutaneous coronary intervention = 4 weeks before inclusion
•Coronary artery bypass graft = 8 weeks before inclusion
•Heart transplantation
•Unstable angina
•Known severe heart failure (LVEF < 35 %)
•Known moderate-severe heart valve disease
•Known severe hypertrophy of left ventricle
•Uncontrolled arrhythmia, 2. or 3. degree AV-block or sick sinus syndrome - assessed from a standard 12-lead electrocardiogram
•Systolic blood pressure < 90 or > 200 mmHg
•Chronic obstructive pulmonary disease or asthma, defined as requirement of daily medical treatment

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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