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

November 21, 2012 updated by: Qijun Shan, The First Affiliated Hospital with Nanjing Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Chun Chen, Professor
        • Sub-Investigator:
          • Weichong Qian, Professor
        • Sub-Investigator:
          • Min Qiu, Doctor
        • Principal Investigator:
          • Zhijian Yang, Professor
        • Principal Investigator:
          • Xiujuan Zhou, Professor
        • Sub-Investigator:
          • Zhenhua Dai, Doctor
        • Sub-Investigator:
          • Jie Gen, Master
        • Sub-Investigator:
          • Zhongxia Zhou, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 24 months
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 months
Myocardial infarction
Time Frame: 24 months
It can be diagnosed by symptoms, ECG and myocardial markers changes.
24 months
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.
24 months
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.
24 months
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.
24 months
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.
24 months
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.
24 months
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.
24 months
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.
24 months
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.
24 months
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.
24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21012-SR-132

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