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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
July 8, 2013
July 17, 2013
September 23, 2015
June 2013
June 2015   (Final data collection date for primary outcome measure)
  • cardiovascular death [ Time Frame: 1 year ]
  • myocardium infarction [ Time Frame: 1 year ]
  • stroke [ Time Frame: 1 year ]
  • repeat revascularization [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01901549 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
 
Unknown status
80
June 2016
June 2015   (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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT01901549
AMIRD
Yes
Not Provided
Not Provided
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
September 2015

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