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Renal Denervation in Patients After Acute Coronary Syndrome (ACSRD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01901549
First Posted: July 17, 2013
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
  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 Intervention Phase
Acute Coronary Syndrome Arterial Hypertension Procedure: Renal denervation Drug: Metoprolol Drug: Lisinopril Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients After Acute Coronary Syndrome

Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • cardiovascular death [ Time Frame: 1 year ]
  • myocardium infarction [ Time Frame: 1 year ]
  • stroke [ Time Frame: 1 year ]
  • repeat revascularization [ Time Frame: 1 year ]

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

Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901549


Contacts
Contact: Evgeny Pokushalov, MD, PhD +79139254858 e.pokushalov@gmail.com

Locations
Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD, PhD    +79139254858    E.Pokushalov@gmail.com   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD         
Sub-Investigator: Alexander Osiev, MD PhD         
Sub-Investigator: Igor Grazhdankin, MD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology
  More Information

Additional Information:
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01901549     History of Changes
Other Study ID Numbers: AMIRD
First Submitted: July 8, 2013
First Posted: July 17, 2013
Last Update Posted: September 23, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Hypertension
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Metoprolol
Lisinopril
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents