An interventional study of RSD and PCI in Coronary Heart Disease, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-11-27.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
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 · Procedure: PCI
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
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.
Also known as: renal sympathetic denervation, renal denervation, renal ablation
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.
Also known as: percutaneous coronary intervention
All-cause mortality
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI
Time frame: 24 months
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.
Time frame: 24 months
Myocardial infarction
It can be diagnosed by symptoms, ECG and myocardial markers changes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
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The First Affiliated Hospital with Nanjing Medical University