Renal Denervation in Patients After Acute Coronary Syndrome
NCT ID: NCT01901549
Last Updated: 2015-09-23
Study Results
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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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2013-06-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PCI+Renal denervation
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.
Metoprolol
Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Lisinopril
ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
PCI alone
Metoprolol
Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Lisinopril
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.
Metoprolol
Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Lisinopril
ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Eligibility Criteria
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Inclusion Criteria
* non stable angina
* significant stenosis
* BP \> 140/90 torr. during more than 1 year
Exclusion Criteria
* Thrombolysis during previous 24 hours
* indications for CABG
18 Years
75 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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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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