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NCT01901549 Clinical Trial

Renal Denervation in Patients After Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— ACSRD  

Official title:
Renal Denervation in Patients After Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01901549
Other study ID # AMIRD
Secondary ID
Status Recruiting
Phase Phase 2
First received July 8, 2013
Last updated September 21, 2015
Start date June 2013
Est. completion date June 2016

Study information
Verified date September 2015
Source Meshalkin Research Institute of Pathology of Circulation
Contact Evgeny Pokushalov, MD, PhD
Phone +79139254858
Email e.pokushalov@gmail.com
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date June 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Renal denervation
The treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.
Drug:
• Metoprolol
Beta-blockers. Optimal medi?al therapy will be assigned according to ACS and STE guidelines.
• Lisinopril
ACE inhibitors. Optimal medi?al therapy will be assigned according to ACS and STE guidelines.

Locations
Country Name City State
Russian Federation State Research Institute of Circulation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary cardiovascular death 1 year Yes
Primary myocardium infarction 1 year Yes
Primary stroke 1 year Yes
Primary repeat revascularization 1 year Yes
Secondary blood pressure changes 1 year No
Secondary CCS and NYHA 1 year No
Secondary heart rhythm disturbances 1 year No
Secondary intima-media index 1 year No
Secondary IVS thickness 1 year No
Secondary restenosis 1 year No
Secondary diastolic disfunction 1 year No
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