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

Primary Purpose

Coronary Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RSD
PCI
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary heart disease, PCI, Renal sympathetic denervation, Hypertension, Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RSD+PCI+Medicine

PCI+Medicine

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

All-cause mortality
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI

Secondary Outcome Measures

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.
Myocardial infarction
It can be diagnosed by symptoms, ECG and myocardial markers changes.
Vascular recanalization again
Coronary angiography shows new stenosis during the follow-up and patients need PCI or coronary artery bypass grafting(CABG) again.
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.
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.
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.
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.
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.
Renal function
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
So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
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.
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.

Full Information

First Posted
November 9, 2012
Last Updated
November 21, 2012
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01733901
Brief Title
Renal Sympathetic Denervation as Secondary Prevention for Patients After Percutaneous Coronary Intervention.
Acronym
RSD4CHD2PRE
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 Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Coronary heart disease, PCI, Renal sympathetic denervation, Hypertension, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RSD+PCI+Medicine
Arm Type
Active Comparator
Arm Description
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).
Arm Title
PCI+Medicine
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
RSD
Other Intervention Name(s)
renal sympathetic denervation, renal denervation, renal ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PCI
Other Intervention Name(s)
percutaneous coronary intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause mortality
Description
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Recurrent angina pectoris
Description
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.
Time Frame
24 months
Title
Myocardial infarction
Description
It can be diagnosed by symptoms, ECG and myocardial markers changes.
Time Frame
24 months
Title
Vascular recanalization again
Description
Coronary angiography shows new stenosis during the follow-up and patients need PCI or coronary artery bypass grafting(CABG) again.
Time Frame
24 months
Title
Chronic heart failure
Description
To study whether RSD can improve the patients' heart function. And it will be judged by the NYHA classification,BNP and echocardiography.
Time Frame
24 months
Title
Arrhythmia
Description
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.
Time Frame
24 months
Title
Stroke
Description
During the follow-up if a new stroke occured,it will be recorded. And it can be diagnosed by symptoms, cranial CT or MRI.
Time Frame
24 months
Title
Blood pressure
Description
To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension,which can be measured by ambulatory blood pressure.
Time Frame
24 months
Title
Blood sugar
Description
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.
Time Frame
24 months
Title
Renal function
Description
To study whether RSD can improve the patients' renal function, which will be measured by urine albumin, creatinine and urea nitrogen levels.
Time Frame
24 months
Title
Pulse wave velocity
Description
So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
Time Frame
24 months
Title
Life quality
Description
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.
Time Frame
24 months
Title
Medication adherence
Description
To study the patients'Medication adherence,we will record the type ,the dose and use time of drugs patients used during the follow-up.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qijun Shan, professor
Phone
0086 025 68136407
Email
qjshan@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qijun Shan, professor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qijun Shan, Professor
First Name & Middle Initial & Last Name & Degree
Zhijian Yang, Professor
First Name & Middle Initial & Last Name & Degree
Chun Chen, Professor
First Name & Middle Initial & Last Name & Degree
Xiujuan Zhou, Professor
First Name & Middle Initial & Last Name & Degree
Weichong Qian, Professor
First Name & Middle Initial & Last Name & Degree
Zhenhua Dai, Doctor
First Name & Middle Initial & Last Name & Degree
Jie Gen, Master
First Name & Middle Initial & Last Name & Degree
Zhongxia Zhou, Master
First Name & Middle Initial & Last Name & Degree
Min Qiu, Doctor

12. IPD Sharing Statement

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

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