Renal Sympathetic Denervation as Secondary Prevention for Patients After Percutaneous Coronary Intervention. (RSD4CHD2PRE)
Coronary Heart Disease
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
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.
Sites / Locations
- First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
RSD+PCI+Medicine
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).
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).