Acute Coronary SyndromePhase 2ACSRDNCT01901549
Renal Denervation in Patients After Acute Coronary Syndrome
A Phase 2 study testing Renal denervation, Metoprolol and Lisinopril in people with Acute Coronary Syndrome and Arterial Hypertension, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Arterial Hypertension
- What is being tested?
- Renal denervation, Metoprolol and Lisinopril
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2013to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute Q negative myocardium infarction (during first 14 days)
- non stable angina
- significant stenosis
- BP > 140/90 torr. during more than 1 year
Who cannot join
- absence of arterial hypertension
- Thrombolysis during previous 24 hours
- indications for CABG
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of Circulation Pathology
Novosibirsk, 630055
Evgeny Pokushalov, MD, PhD, +79139254858, E.Pokushalov@gmail.com
Evgeny Pokushalov, MD, PhD
About 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.
- Conditions
- Acute Coronary Syndrome, Arterial Hypertension
- Being tested
- Renal denervation, Metoprolol, Lisinopril
- Medical subject headings
- Acute Coronary Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationProcedure or surgery
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.
MetoprololDrug
Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
LisinoprilDrug
ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
| Study group | Role | What they receive |
|---|---|---|
| PCI+Renal denervation | Active comparator | Not described Receives: Procedure: Renal denervation; Drug: Metoprolol; Drug: Lisinopril |
| PCI alone | Active comparator | Not described Receives: Drug: Metoprolol; Drug: Lisinopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular death
Measured: 1 year
myocardium infarction
Measured: 1 year
stroke
Measured: 1 year
repeat revascularization
Measured: 1 year
Secondary outcomes (7)
blood pressure changes
Measured: 1 year
CCS and NYHA
Measured: 1 year
heart rhythm disturbances
Measured: 1 year
intima-media index
Measured: 1 year
IVS thickness
Measured: 1 year
restenosis
Measured: 1 year
diastolic disfunction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Evgeny Pokushalov, MD, PhD, Principal investigator, State Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901549
- Sponsor's protocol ID
- AMIRD
- Acronym
- ACSRD
- Status last verified
- Sep 2015
- First submitted
- 8 Jul 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation in Patients After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01901549
- Acronym / sponsor ID
- ACSRD / AMIRD
- Conditions
- Acute Coronary Syndrome, Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI+Renal denervation | Active comparator | Procedure: Renal denervation, Drug: Metoprolol, Drug: Lisinopril |
| PCI alone | Active comparator | Drug: Metoprolol, Drug: Lisinopril |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute Q negative myocardium infarction (during first 14 days)
- non stable angina
- significant stenosis
- BP > 140/90 torr. during more than 1 year
Key exclusion criteria (3 listed)
- absence of arterial hypertension
- Thrombolysis during previous 24 hours
- indications for CABG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | PCI+Renal denervation |
| MetoprololBeta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines. | Drug | PCI alone, PCI+Renal denervation |
| LisinoprilACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines. | Drug | PCI alone, PCI+Renal denervation |
Primary outcome
cardiovascular death
Time frame: 1 year
myocardium infarction
Time frame: 1 year
stroke
Time frame: 1 year
repeat revascularization
Time frame: 1 year
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- State Research Institute of Circulation Pathology Official SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeny Pokushalov, MD, PhD principal investigator
State Research Institute of Circulation Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renal denervation, Metoprolol and Lisinopril in people with Acute Coronary Syndrome and Arterial Hypertension, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Pokushalov, MD, PhD (+79139254858, e.pokushalov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular death (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.