Renal Denervation in Patients After Acute Coronary Syndrome

Phase 2

• Conditions: Acute Coronary Syndrome; Arterial Hypertension
• Interventions: Procedure: Renal denervation; Drug: Metoprolol; Drug: Lisinopril

• Registration Number: NCT01901549
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

This study is aimed to evaluate the effect of renal denervation to decreasing blood pressure and left ventricle remodeling progression in patients after acute coronary syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-17
• Primary Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• acute Q negative myocardium infarction (during first 14 days)
• non stable angina
• significant stenosis
• BP > 140/90 torr. during more than 1 year

Exclusion Criteria

• absence of arterial hypertension
• Thrombolysis during previous 24 hours
• indications for CABG

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI+Renal denervation	Renal denervation	-
PCI+Renal denervation	Metoprolol	-
PCI alone	Lisinopril	-
PCI alone	Metoprolol	-
PCI+Renal denervation	Lisinopril	-

Primary Outcome Measures

Name	Time	Method
cardiovascular death	1 year
myocardium infarction	1 year
stroke	1 year
repeat revascularization	1 year

Secondary Outcome Measures

Name	Time	Method
diastolic disfunction	1 year
restenosis	1 year
blood pressure changes	1 year
CCS and NYHA	1 year
heart rhythm disturbances	1 year
intima-media index	1 year
IVS thickness	1 year

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation