Renal Denervation in Patients After Acute Coronary Syndrome (ACSRD)

September 21, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of Circulation Pathology
        • Sub-Investigator:
          • Alexander Romanov, MD
        • Sub-Investigator:
          • Alexander Osiev, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCI+Renal denervation
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 mediсal therapy will be assigned according to ACS and STE guidelines.
Drug: Lisinopril
ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Active Comparator: PCI alone
Drug: Metoprolol
Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Drug: Lisinopril
ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stroke
Time Frame: 1 year
1 year
repeat revascularization
Time Frame: 1 year
1 year
cardiovascular death
Time Frame: 1 year
1 year
myocardium infarction
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure changes
Time Frame: 1 year
1 year
CCS and NYHA
Time Frame: 1 year
1 year
heart rhythm disturbances
Time Frame: 1 year
1 year
intima-media index
Time Frame: 1 year
1 year
IVS thickness
Time Frame: 1 year
1 year
restenosis
Time Frame: 1 year
1 year
diastolic disfunction
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Evgeny Pokushalov, MD, PhD, State Research Institute of Circulation Pathology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMIRD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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