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

July 8, 2013
February 3, 2014
June 2013
June 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01901549 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Renal Denervation in Patients After Acute Coronary Syndrome
Renal Denervation in Patients After Acute Coronary Syndrome

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Arterial Hypertension
  • 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+Renal denervation
    Interventions:
    • Procedure: Renal denervation
    • Drug: Metoprolol
    • Drug: Lisinopril
  • Active Comparator: PCI alone
    Interventions:
    • Drug: Metoprolol
    • Drug: Lisinopril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2016
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Evgeny Pokushalov, MD, PhD +79139254858 e.pokushalov@gmail.com
Russian Federation
 
NCT01901549
AMIRD
Yes
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Principal Investigator: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology
Meshalkin Research Institute of Pathology of Circulation
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP