Coronary Heart DiseaseRSD4CHD2PRENCT01733901
Renal Sympathetic Denervation as Secondary Prevention for Patients After Percutaneous Coronary Intervention.
A study testing RSD and PCI in people with Coronary Heart Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To study whether renal sympathetic denervation(RSD) will reduce the all-cause mortality and the recurrence rate of a composite of cardiovascular event(including angina, myocardial infarction, repeat percutaneous coronary intervention and coronary artery bypass grafting) in patients after percutaneous coronary… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- RSD and PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Jul 2015
- Phase
- Interventional
- 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
- Individual is ≥ 18 and ≤75 years of age.
- Individual has a clear history of coronary heart disease,and need underwent percutaneous coronary intervention .
- Blood pressure >115/75mmHg.
- Individual's cardiac function is between Ⅰ~Ⅲ level(NYHA)
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study
Who cannot join
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Individual has experienced renal artery stenosis,or A history of prior renal artery intervention including balloon angioplasty or stenting. or ineligible conditions through renal artery Computed Tomography Angiogram(CTA) inspection, such as double renal artery on one side,renal artery length≤2cm, diameter≤4mm, and distortion at incept sect.
- Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD calculation.
- Individual has Acute heart failure.
- Individual has experienced a cerebrovascular accident within 3 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has experienced sick sinus syndrome.
Show all 10Show fewer
- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
- Individual is pregnant, nursing or planning to be pregnant. [Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.]
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Qijun Shan, Professor
Zhijian Yang, Professor
About this study
Official title: Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation as a Method of Secondary Prevention for Patients After Percutaneous Coronary Intervention.
To study whether renal sympathetic denervation(RSD) will reduce the all-cause mortality and the recurrence rate of a composite of cardiovascular event(including angina, myocardial infarction, repeat percutaneous coronary intervention and coronary artery bypass grafting) in patients after percutaneous coronary intervention(PCI). Besides whether RSD can reduce the risk factors for coronary heart disease.
Read the detailed description
Coronary heart disease is the leading cause of death worldwide, contributing to over 7.2 million deaths annually. The main measures of secondary prevention of coronary heart disease are optimizing drug therapy and changing lifestyle. optimizing drug therapy, including aspirin, beta receptor blockers, lipid regulating drugs (mostly statins, a small part fibrates) and vascular angiotensin-converting enzyme inhibitors. However, the situation for secondary prevention of coronary heart disease is not satisfying. EuroASPIRE III survey found that despite effective drug used in the primary or secondary prevention of coronary heart disease, coronary heart disease risk factors, such as high blood glucose,hypertension, high cholesterol and obesity, are still poorly controlled. At the same time sympathetic activation plays an extremely important role in the development of coronary heart disease, and high sympathetic activity after acute myocardial infarction is closely related to malignant arrhythmia and heart failure. Recently, many clinical researches have verified that catheter-based renal sympathetic denervation(RSD) can safely be used to substantially reduce blood pressure, reduce left ventricular hypertrophy, improve glucose tolerance and sleep apnea severity. Simultaneously, a marked reduction in muscle and whole-body sympathetic-nerve activity(MSNA) is apparent, with a decrease in renal and whole-body norepinephrine spillover. Hypertension, diabetes, high norepinephrine level and obstructive sleep apnea are all recognized as risk factors for the development and recurrence of coronary heart disease. So, we design this randomized parallel control clinical study to demonstrate whether RSD can reduce the mortality and the recurrence rate of a composite of cardiovascular event in patients after PCI, besides whether RSD can reduce the risk factors for coronary heart disease.
- Conditions
- Coronary Heart Disease
- Being tested
- RSD, PCI
- Keywords
- Coronary heart disease, PCI, Renal sympathetic denervation, Hypertension, Diabetes
- Medical subject headings
- Coronary Disease, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSDProcedure or surgery
Also called renal sympathetic denervation, renal denervation, renal ablation
Contrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celcius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About six to nine ablations at 10 W for 1 min each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
PCIProcedure or surgery
Also called percutaneous coronary intervention
Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the stenotic coronary arteries of the heart found in CHD. During PCI, a cardiologist feeds a deflated balloon or other device on a catheter from the inguinal femoral artery or radial artery up through blood vessels until they reach the site of blockage in the heart. X-ray imaging is used to guide the catheter threading. At the blockage, the balloon is inflated to open the artery, allowing blood to flow. A stent is often placed at the site of blockage to permanently open the artery.
| Study group | Role | What they receive |
|---|---|---|
| RSD+PCI+Medicine | Active comparator | We will recruit 300 randomised CHD patients who meet the inclusion criteria. First undergo percutaneous coronary intervention, and then perform the renal artery angiography procedure to confirm anatomy. If renal artery meet the inclusion criteria, give the renal sympathetic denervation. After renal sympathetic denervation traditional secondary prevention of coronary heart disease is recommend. Finally we will conduct a clinic follow-up every six month and a telephone follow-up every three month(Total 24 months). Receives: Procedure: RSD; Procedure: PCI |
| PCI+Medicine | Placebo comparator | We aslo will recruit 300 randomised CHD patients who meet the inclusion criteria. There are no significant differences in age, gender, race, past medical history,personal history and so on between the two groups. In this group we will perform percutaneous coronary intervention firstly, then give traditional secondary prevention of coronary heart disease just like the RSD+PCI+Medicine group. Third we will conduct a clinic follow-up every six month and a telephone follow-up every three month(Total 24 months). Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI
Measured: 24 months
Secondary outcomes (12)
Recurrent angina pectoris
Previous symptoms of myocardial ischemia in patients relapsed or aggravated during follow-up, or ECG ST segment depressed compared with preoperative, or need to increase the dose of antianginal drug.
Measured: 24 months
Myocardial infarction
It can be diagnosed by symptoms, ECG and myocardial markers changes.
Measured: 24 months
Vascular recanalization again
Coronary angiography shows new stenosis during the follow-up and patients need PCI or coronary artery bypass grafting(CABG) again.
Measured: 24 months
Chronic heart failure
To study whether RSD can improve the patients' heart function. And it will be judged by the NYHA classification,BNP and echocardiography.
Measured: 24 months
Arrhythmia
If a new arrhythmia is discovered during the follow-up,it will be recorded. Patients may have symptoms of flustered, palpitations, dizziness, amaurosis, syncope and so on, which can be diagnosed by ECG and Holter.
Measured: 24 months
Stroke
During the follow-up if a new stroke occured,it will be recorded. And it can be diagnosed by symptoms, cranial CT or MRI.
Measured: 24 months
Blood pressure
To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension,which can be measured by ambulatory blood pressure.
Measured: 24 months
Blood sugar
In order to study whether RSD can reduce the blood sugar level and insulin resistance of diabetic patients. It will be measured by fasting blood glucose, glycated hemoglobin and fasting insulin.
Measured: 24 months
Renal function
To study whether RSD can improve the patients' renal function, which will be measured by urine albumin, creatinine and urea nitrogen levels.
Measured: 24 months
Pulse wave velocity
So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
Measured: 24 months
Life quality
Life quality on 36-item short-form(SF-36)Health Survey Questionnaire will be carried out during the follow-up to study the patients' life quality.
Measured: 24 months
Medication adherence
To study the patients'Medication adherence,we will record the type ,the dose and use time of drugs patients used during the follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qijun Shan, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Qijun Shan, professor, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733901
- Sponsor's protocol ID
- 21012-SR-132
- Acronym
- RSD4CHD2PRE
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation as a Method of Secondary Prevention for Patients After Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT01733901
- Acronym / sponsor ID
- RSD4CHD2PRE / 21012-SR-132
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease, PCI, Renal sympathetic denervation, Hypertension, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 27 Nov 2012 (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.
To study whether renal sympathetic denervation(RSD) will reduce the all-cause mortality and the recurrence rate of a composite of cardiovascular event(including angina, myocardial infarction, repeat percutaneous coronary intervention and coronary artery bypass grafting) in patients after percutaneous coronary intervention(PCI). Besides whether RSD can reduce the risk factors for coronary heart disease.
Detailed description
Coronary heart disease is the leading cause of death worldwide, contributing to over 7.2 million deaths annually. The main measures of secondary prevention of coronary heart disease are optimizing drug therapy and changing lifestyle. optimizing drug therapy, including aspirin, beta receptor blockers, lipid regulating drugs (mostly statins, a small part fibrates) and vascular angiotensin-converting enzyme inhibitors. However, the situation for secondary prevention of coronary heart disease is not satisfying. EuroASPIRE III survey found that despite effective drug used in the primary or secondary prevention of coronary heart disease, coronary heart disease risk factors, such as high blood glucose,hypertension, high cholesterol and obesity, are still poorly controlled. At the same time sympathetic activation plays an extremely important role in the development of coronary heart disease, and high sympathetic activity after acute myocardial infarction is closely related to malignant arrhythmia and heart failure. Recently, many clinical researches have verified that catheter-based renal sympathetic denervation(RSD) can safely be used to substantially reduce blood pressure, reduce left ventricular hypertrophy, improve glucose tolerance and sleep apnea severity. Simultaneously, a marked reduction in muscle and whole-body sympathetic-nerve activity(MSNA) is apparent, with a decrease in renal and whole-body norepinephrine spillover. Hypertension, diabetes, high norepinephrine level and obstructive sleep apnea are all recognized as risk factors for the development and recurrence of coronary heart disease. So, we design this randomized parallel control clinical study to demonstrate whether RSD can reduce the mortality and the recurrence rate of a composite of cardiovascular event in patients after PCI, besides whether RSD can reduce the risk factors for coronary heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSD+PCI+Medicine | Active comparator | Procedure: RSD, Procedure: PCIWe will recruit 300 randomised CHD patients who meet the inclusion criteria. First undergo percutaneous coronary intervention, and then perform the renal artery angiography procedure to confirm anatomy. If renal artery meet the inclusion criteria, give the renal sympathetic denervation. After renal sympathetic denervation traditional secondary prevention of coronary heart disease is recommend. Finally we will conduct a clinic follow-up every six month and a telephone follow-up every three month(Total 24 months). |
| PCI+Medicine | Placebo comparator | Procedure: PCIWe aslo will recruit 300 randomised CHD patients who meet the inclusion criteria. There are no significant differences in age, gender, race, past medical history,personal history and so on between the two groups. In this group we will perform percutaneous coronary intervention firstly, then give traditional secondary prevention of coronary heart disease just like the RSD+PCI+Medicine group. Third we will conduct a clinic follow-up every six month and a telephone follow-up every three month(Total 24 months). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individual is ≥ 18 and ≤75 years of age.
- Individual has a clear history of coronary heart disease,and need underwent percutaneous coronary intervention .
- Blood pressure >115/75mmHg.
- Individual's cardiac function is between Ⅰ~Ⅲ level(NYHA)
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study
Key exclusion criteria (10 listed)
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Individual has experienced renal artery stenosis,or A history of prior renal artery intervention including balloon angioplasty or stenting. or ineligible conditions through renal artery Computed Tomography Angiogram(CTA) inspection, such as double renal artery on one side,renal artery length≤2cm, diameter≤4mm, and distortion at incept sect.
- Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD calculation.
- Individual has Acute heart failure.
- Individual has experienced a cerebrovascular accident within 3 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
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 |
|---|---|---|
| RSDAlso: renal sympathetic denervation, renal denervation, renal ablationContrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celcius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About six to nine ablations at 10 W for 1 min each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. | Procedure or surgery | RSD+PCI+Medicine |
| PCIAlso: percutaneous coronary interventionPercutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the stenotic coronary arteries of the heart found in CHD. During PCI, a cardiologist feeds a deflated balloon or other device on a catheter from the inguinal femoral artery or radial artery up through blood vessels until they reach the site of blockage in the heart. X-ray imaging is used to guide the catheter threading. At the blockage, the balloon is inflated to open the artery, allowing blood to flow. A stent is often placed at the site of blockage to permanently open the artery. | Procedure or surgery | PCI+Medicine, RSD+PCI+Medicine |
Primary outcome
All-cause mortality
Time frame: 24 months
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI
12 secondary outcomes
Recurrent angina pectoris
Time frame: 24 months
Myocardial infarction
Time frame: 24 months
Vascular recanalization again
Time frame: 24 months
Chronic heart failure
Time frame: 24 months
Arrhythmia
Time frame: 24 months
Stroke
Time frame: 24 months
Blood pressure
Time frame: 24 months
Blood sugar
Time frame: 24 months
Renal function
Time frame: 24 months
Pulse wave velocity
Time frame: 24 months
Life quality
Time frame: 24 months
Medication adherence
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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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.
Qijun Shan, professor study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSD and PCI in people with Coronary Heart Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 5 inclusion and 10 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 27 Nov 2012. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Qijun Shan, professor (0086 025 68136407, qjshan@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 24 months). 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 27 Nov 2012.