search
Back to results

Renal Denervation in Patients After Acute Coronary Syndrome (ACSRD)

Primary Purpose

Acute Coronary Syndrome, Arterial Hypertension

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Renal denervation
Metoprolol
Lisinopril
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PCI+Renal denervation

PCI alone

Arm Description

Outcomes

Primary Outcome Measures

cardiovascular death
myocardium infarction
stroke
repeat revascularization

Secondary Outcome Measures

blood pressure changes
CCS and NYHA
heart rhythm disturbances
intima-media index
IVS thickness
restenosis
diastolic disfunction

Full Information

First Posted
July 8, 2013
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
search

1. Study Identification

Unique Protocol Identification Number
NCT01901549
Brief Title
Renal Denervation in Patients After Acute Coronary Syndrome
Acronym
ACSRD
Official Title
Renal Denervation in Patients After Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCI+Renal denervation
Arm Type
Active Comparator
Arm Title
PCI alone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Renal denervation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Description
Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Intervention Description
ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Primary Outcome Measure Information:
Title
cardiovascular death
Time Frame
1 year
Title
myocardium infarction
Time Frame
1 year
Title
stroke
Time Frame
1 year
Title
repeat revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
blood pressure changes
Time Frame
1 year
Title
CCS and NYHA
Time Frame
1 year
Title
heart rhythm disturbances
Time Frame
1 year
Title
intima-media index
Time Frame
1 year
Title
IVS thickness
Time Frame
1 year
Title
restenosis
Time Frame
1 year
Title
diastolic disfunction
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
e.pokushalov@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD
First Name & Middle Initial & Last Name & Degree
Alexander Osiev, MD PhD
First Name & Middle Initial & Last Name & Degree
Igor Grazhdankin, MD

12. IPD Sharing Statement

Links:
URL
http://meshalkin.ru
Description
State Research Institute of Circulation Pathology Official Site

Learn more about this trial

Renal Denervation in Patients After Acute Coronary Syndrome

We'll reach out to this number within 24 hrs