Coronary Heart Disease Clinical Trial
— RSD4CHD2PREOfficial title:
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | July 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 ?~? 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
Secondary | Myocardial infarction | It can be diagnosed by symptoms, ECG and myocardial markers changes. | 24 months | Yes |
Secondary | Vascular recanalization again | Coronary angiography shows new stenosis during the follow-up and patients need PCI or coronary artery bypass grafting(CABG) again. | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
Secondary | Renal function | To study whether RSD can improve the patients' renal function, which will be measured by urine albumin, creatinine and urea nitrogen levels. | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
Secondary | 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. | 24 months | Yes |
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