Renal Sympathetic Denervation as Secondary Prevention for Patients After Percutaneous Coronary Intervention. (RSD4CHD2PRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by The First Hospital of Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Qijun Shan, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01733901
First received: November 9, 2012
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Procedure: RSD
Procedure: PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by The First Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI


Secondary Outcome Measures:
  • Recurrent angina pectoris [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.

  • Myocardial infarction [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    It can be diagnosed by symptoms, ECG and myocardial markers changes.

  • Vascular recanalization again [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Coronary angiography shows new stenosis during the follow-up and patients need PCI or coronary artery bypass grafting(CABG) again.

  • Chronic heart failure [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    To study whether RSD can improve the patients' heart function. And it will be judged by the NYHA classification,BNP and echocardiography.

  • Arrhythmia [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.

  • Stroke [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    During the follow-up if a new stroke occured,it will be recorded. And it can be diagnosed by symptoms, cranial CT or MRI.

  • Blood pressure [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension,which can be measured by ambulatory blood pressure.

  • Blood sugar [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.

  • Renal function [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    To study whether RSD can improve the patients' renal function, which will be measured by urine albumin, creatinine and urea nitrogen levels.

  • Pulse wave velocity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.

  • Life quality [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.

  • Medication adherence [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    To study the patients'Medication adherence,we will record the type ,the dose and use time of drugs patients used during the follow-up.


Estimated Enrollment: 600
Study Start Date: November 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RSD+PCI+Medicine
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).
Procedure: RSD
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.
Other Names:
  • renal sympathetic denervation
  • renal denervation
  • renal ablation
Procedure: PCI
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.
Other Name: percutaneous coronary intervention
Placebo Comparator: PCI+Medicine
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).
Procedure: PCI
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.
Other Name: percutaneous coronary intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individual is ≥ 18 and ≤75 years of age.
  2. Individual has a clear history of coronary heart disease,and need underwent percutaneous coronary intervention .
  3. Blood pressure >115/75mmHg.
  4. Individual's cardiac function is between Ⅰ~Ⅲ level(NYHA)
  5. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

  1. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
  2. 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.
  3. Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD calculation.
  4. Individual has Acute heart failure.
  5. Individual has experienced a cerebrovascular accident within 3 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
  6. Individual has experienced sick sinus syndrome.
  7. 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).
  8. 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.]
  9. 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.
  10. Individual is currently enrolled in another investigational drug or device trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733901

Contacts
Contact: Qijun Shan, professor 0086 025 68136407 qjshan@njmu.edu.cn

Locations
China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210000
Principal Investigator: Qijun Shan, Professor         
Principal Investigator: Zhijian Yang, Professor         
Principal Investigator: Chun Chen, Professor         
Principal Investigator: Xiujuan Zhou, Professor         
Sub-Investigator: Weichong Qian, Professor         
Sub-Investigator: Zhenhua Dai, Doctor         
Sub-Investigator: Jie Gen, Master         
Sub-Investigator: Zhongxia Zhou, Master         
Sub-Investigator: Min Qiu, Doctor         
Sponsors and Collaborators
The First Hospital of Nanjing Medical University
Investigators
Study Chair: Qijun Shan, professor the First Affiliated Hospital of Nanjing Medical University
  More Information

No publications provided

Responsible Party: Qijun Shan, Professor,Director, Cardiac Arrhythmia Group, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01733901     History of Changes
Other Study ID Numbers: 21012-SR-132
Study First Received: November 9, 2012
Last Updated: November 21, 2012
Health Authority: China: Ethics Committee

Keywords provided by The First Hospital of Nanjing Medical University:
Coronary heart disease
PCI
Renal sympathetic denervation
Hypertension
Diabetes

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014