Acute Coronary Syndrome | Renal Denervation in Patients After Acute Coronary Syndrome
Acute Coronary Syndrome research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Coronary Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Renal denervationThe 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:MetoprololBeta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Drug:LisinoprilACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: June 2013
Completed Date: June 2016
Phase: Phase 2
Primary Outcome: cardiovascular death
Secondary Outcome: blood pressure changes
Study sponsors, principal investigator, and references
Principal Investigator: Evgeny Pokushalov, MD, PhD
Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation