Renal Denervation in Patients After Acute Coronary Syndrome

NCT ID: NCT01901549

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PCI+Renal denervation

Group Type ACTIVE_COMPARATOR

Renal denervation

Intervention Type PROCEDURE

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.

Metoprolol

Intervention Type DRUG

Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

Lisinopril

Intervention Type DRUG

ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

PCI alone

Group Type ACTIVE_COMPARATOR

Metoprolol

Intervention Type DRUG

Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

Lisinopril

Intervention Type DRUG

ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

Interventions

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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.

Intervention Type PROCEDURE

Metoprolol

Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

Intervention Type DRUG

Lisinopril

ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evgeny Pokushalov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State Research Institute of Circulation Pathology

Locations

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State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Evgeny Pokushalov, MD, PhD

Role: CONTACT

+79139254858

Facility Contacts

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Evgeny Pokushalov, MD, PhD

Role: primary

+79139254858

Related Links

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http://meshalkin.ru

State Research Institute of Circulation Pathology Official Site

Other Identifiers

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AMIRD

Identifier Type: -

Identifier Source: org_study_id

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