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Renal Denervation in Patients After Acute Coronary Syndrome (ACSRD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients After Acute Coronary Syndrome

Resource links provided by NLM:


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

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 ]

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 ]

Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01901549     History of Changes
Other Study ID Numbers: AMIRD
Study First Received: July 8, 2013
Last Updated: February 3, 2014
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Acute Coronary Syndrome
Hypertension
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014