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

NCT01733901 | Unknown DMC

• 1 other identifier: 21012-SR-132
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Heart Disease

Keywords

Coronary heart disease; PCI; Renal sympathetic denervation; Hypertension; Diabetes

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  To study the effect of renal sympathetic denervation(RSD) on all-cause mortality in patients after PCI

  24 months

Secondary Outcomes (12)

• Recurrent angina pectoris

  24 months

• Myocardial infarction

  24 months

• Vascular recanalization again

  24 months

• Chronic heart failure

  24 months

• Arrhythmia

  24 months

Study Arms (2)

RSD+PCI+Medicine

ACTIVE COMPARATOR

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

PCI+Medicine

PLACEBO COMPARATOR

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

Interventions

RSD PROCEDURE

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

RSD+PCI+Medicine

PCI PROCEDURE

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

PCI+Medicine; RSD+PCI+Medicine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Hypertension; Diabetes Mellitus

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Qijun Shan, professor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Qijun Shan, professor

CONTACT

0086 025 68136407; qjshan@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor，Director, Cardiac Arrhythmia Group

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: July 1, 2015
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

CN (1)