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

• ClinicalTrials.gov Identifier: NCT01733901
• Recruitment Status: Unknown
• First Posted: November 27, 2012
• Last Update Posted: November 27, 2012
• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Information provided by (Responsible Party): Qijun Shan, The First Affiliated Hospital with Nanjing Medical University

Study Description

Brief 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 intervention(PCI). Besides whether RSD can reduce the risk factors for coronary heart disease.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease	Procedure: RSD; Procedure: PCI	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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.
• Study Start Date: November 2012
• Estimated Primary Completion Date: November 2014
• Estimated Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. All-cause mortality [ Time Frame: 24 months ]
   To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI

Secondary Outcome Measures :

1. Recurrent angina pectoris [ Time Frame: 24 months ]
   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.
2. Myocardial infarction [ Time Frame: 24 months ]
   It can be diagnosed by symptoms, ECG and myocardial markers changes.
3. Vascular recanalization again [ Time Frame: 24 months ]
   Coronary angiography shows new stenosis during the follow-up and patients need PCI or coronary artery bypass grafting(CABG) again.
4. Chronic heart failure [ Time Frame: 24 months ]
   To study whether RSD can improve the patients' heart function. And it will be judged by the NYHA classification,BNP and echocardiography.
5. Arrhythmia [ Time Frame: 24 months ]
   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.
6. Stroke [ Time Frame: 24 months ]
   During the follow-up if a new stroke occured,it will be recorded. And it can be diagnosed by symptoms, cranial CT or MRI.
7. Blood pressure [ Time Frame: 24 months ]
   To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension,which can be measured by ambulatory blood pressure.
8. Blood sugar [ Time Frame: 24 months ]
   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.
9. Renal function [ Time Frame: 24 months ]
   To study whether RSD can improve the patients' renal function, which will be measured by urine albumin, creatinine and urea nitrogen levels.
10. Pulse wave velocity [ Time Frame: 24 months ]
    So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
11. Life quality [ Time Frame: 24 months ]
    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.
12. Medication adherence [ Time Frame: 24 months ]
    To study the patients'Medication adherence,we will record the type ,the dose and use time of drugs patients used during the follow-up.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 Affiliated Hospital with Nanjing Medical University

Investigators

• Study Chair: Qijun Shan, professor; The First Affiliated Hospital with Nanjing Medical University

More Information

• Responsible Party: Qijun Shan, Professor，Director, Cardiac Arrhythmia Group, The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT01733901
• Other Study ID Numbers: 21012-SR-132
• First Posted: November 27, 2012
• Last Update Posted: November 27, 2012
• Last Verified: November 2012

Keywords provided by Qijun Shan, The First Affiliated Hospital with Nanjing Medical University:

Coronary heart disease; PCI; Renal sympathetic denervation; Hypertension; Diabetes

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases