Renal Sympathetic Denervation as Secondary Prevention for Patients After Percutaneous Coronary In… (NCT01733901) | Clinical Trial Compass
UnknownNot Applicable
Renal Sympathetic Denervation as Secondary Prevention for Patients After Percutaneous Coronary Intervention.
China600 participantsStarted 2012-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 â… \~â…¢ 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.
✕
What they're measuring
1
All-cause mortality
Timeframe: 24 months
Trial details
NCT IDNCT01733901
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. 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. \[Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.\]