Renal Denervation in Patients After Acute Coronary Syndrome | RxWiki

Renal Denervation in Patients After Acute Coronary Syndrome

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Acute Coronary Syndrome Arterial Hypertension
Intervention	Procedure: Renal denervation Drug: Metoprolol Drug: Lisinopril
Phase	Phase 2
Sponsor	Meshalkin Research Institute of Pathology of Circulation
Responsible Party	Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier	NCT01901549
First Received	July 8, 2013
Last Updated	February 3, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	July 8, 2013
Last Updated Date	February 3, 2014
Start Date	June 2013
Estimated Primary Completion Date	June 2016
Current Primary Outcome Measures	cardiovascular death [Time Frame: 1 year] [Designated as safety issue: Yes] myocardium infarction [Time Frame: 1 year] [Designated as safety issue: Yes] stroke [Time Frame: 1 year] [Designated as safety issue: Yes] repeat revascularization [Time Frame: 1 year] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	blood pressure changes [Time Frame: 1 year] [Designated as safety issue: No] CCS and NYHA [Time Frame: 1 year] [Designated as safety issue: No] heart rhythm disturbances [Time Frame: 1 year] [Designated as safety issue: No] intima-media index [Time Frame: 1 year] [Designated as safety issue: No] IVS thickness [Time Frame: 1 year] [Designated as safety issue: No] restenosis [Time Frame: 1 year] [Designated as safety issue: No] diastolic disfunction [Time Frame: 1 year] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Renal Denervation in Patients After Acute Coronary Syndrome
Official Title	Renal Denervation in Patients After Acute Coronary Syndrome
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Condition	Acute Coronary Syndrome Arterial Hypertension
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 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.
Study Arm (s)	Active Comparator: PCI+Renal denervation Active Comparator: PCI alone

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	80
Estimated Completion Date	June 2016
Estimated Primary Completion Date	June 2014
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Evgeny Pokushalov, MD, PhD +79139254858 e.pokushalov@gmail.com
Location Countries	Russian Federation

Administrative Information[ + expand ][ + ]

NCT Number	NCT01901549
Other Study ID Numbers	AMIRD
Has Data Monitoring Committee	Yes
Information Provided By	Meshalkin Research Institute of Pathology of Circulation
Study Sponsor	Meshalkin Research Institute of Pathology of Circulation
Collaborators	Not Provided
Investigators	Principal Investigator: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology
Verification Date	February 2014

Locations[ + expand ][ + ]

State Research Institute of Circulation Pathology	Novosibirsk, Russian Federation, 630055 Contact: Evgeny Pokushalov, MD, PhD \| +79139254858 \| E.Pokushalov@gmail.com Principal Investigator: Evgeny Pokushalov, MD, PhD Recruiting