Actively Recruiting
Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.
Led by Ryazan State Medical University · Updated on 2023-07-06
120
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease undergoing open reconstructive interventions.
CONDITIONS
Official Title
Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease confirmed by ultrasonography or angiography
You will not qualify if you...
- Men or women under 18 years of age
- History of anaphylaxis
- Hypersensitivity to Slavinorm�ae components or animal proteins
- Absolute or relative contraindications to treadmill test
- Inability to walk at 3.2 km/h (2 mph) for at least 2 minutes during screening stress test
- ST segment depression greater than 1 mm on electrocardiogram
- Peripheral artery disease not caused by atherosclerosis
- Previous reconstructive surgery or invasive interventions on lower extremity arteries without intermittent claudication
- Angina pectoris functional class III-IV according to CCS
- Body mass index over 35 kg/m2
- Acute or chronic renal failure (creatinine clearance less than 30 ml/min)
- Liver failure with AST or ALT more than 3 times upper limit of normal
- Chronic heart failure functional class III-IV according to NYHA
- Acute coronary syndrome within 6 months before screening
- Any other clinically significant condition or comorbidity that would prevent participation based on investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
RyazanSMU
Ryazan, Russia
Actively Recruiting
Research Team
I
Igor Aleksadrovich Suchkov
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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