Renal Denervation in Patients After Acute Coronary Syndrome
ACSRD
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 8, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 23, 2015
September 1, 2015
2 years
July 8, 2013
September 21, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
cardiovascular death
1 year
myocardium infarction
1 year
stroke
1 year
repeat revascularization
1 year
Secondary Outcomes (7)
blood pressure changes
1 year
CCS and NYHA
1 year
heart rhythm disturbances
1 year
intima-media index
1 year
IVS thickness
1 year
- +2 more secondary outcomes
Study Arms (2)
PCI+Renal denervation
ACTIVE COMPARATORPCI alone
ACTIVE COMPARATORInterventions
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.
Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
Eligibility Criteria
You may qualify if:
- acute Q negative myocardium infarction (during first 14 days)
- non stable angina
- significant stenosis
- BP \> 140/90 torr. during more than 1 year
You may not qualify if:
- absence of arterial hypertension
- Thrombolysis during previous 24 hours
- indications for CABG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evgeny Pokushalov, MD, PhD
State Research Institute of Circulation Pathology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2013
First Posted
July 17, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2016
Last Updated
September 23, 2015
Record last verified: 2015-09