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Renal Denervation in Patients After Acute Coronary Syndrome

Renal Denervation in Patients After Acute Coronary Syndrome

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01901549
Acronym
ACSRD
Enrollment
80
Registered
2013-07-17
Start date
2013-06-30
Completion date
2016-06-30
Last updated
2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Arterial Hypertension

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.

Interventions

PROCEDURERenal 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.

DRUGMetoprolol

Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

DRUGLisinopril

ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
cardiovascular death1 year
myocardium infarction1 year
stroke1 year
repeat revascularization1 year

Secondary

MeasureTime frame
IVS thickness1 year
blood pressure changes1 year
diastolic disfunction1 year
restenosis1 year
CCS and NYHA1 year
heart rhythm disturbances1 year
intima-media index1 year

Countries

Russia

Contacts

Primary ContactEvgeny Pokushalov, MD, PhD
e.pokushalov@gmail.com+79139254858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026