Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Effect of Electro-Acupuncture on Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00932139
First received: July 1, 2009
Last updated: October 14, 2010
Last verified: October 2010
History of Changes
  Purpose

Based on previous published research in animals, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension.


Condition Intervention Phase
Hypertension
Arrhythmias
 Procedure: Electro-acupuncture
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Neural Mechanism of the Effect of Acupuncture on Myocardial Ischemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Reduction in blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Echocardiographic transthoracic output (CO) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) plasma catecholamines and renin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 94
Study Start Date: February 2003
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood Pressure
Acupuncture
 Procedure: Electro-acupuncture
First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heartrate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
Other Names:
  • Blood pressure
  • Hypertension
  • Arrythmias

Detailed Description:

The purpose of this study is to prove: (1) Myocardial ischemia, cardiac arrhythmias and hypertensive response at rest and provoked by stress are decreased by EA; (2) The mechanism of the ischemic response is an imbalance between myocardial oxygen supply and demand originating as an increase in autonomic nervous system sympathetic activity causing increased oxygen demand. EA inhibits the sympathetic nervous system, decreases blood pressure and reduces the oxygen demand. Our prior data in animals shows that improvements in cardiovascular function during myocardial ischemia are mediated by an EA-induced sensory neural reflex originating in somatic nerves to reduce sympathetic nerve activity. The specific aims of the present study will allow us to better understand and modulate the sympathetic nervous discharge activity that can precipitate coronary ischemia, arrhythmias and hypertension in exercise stress in humans. Potential clinical application is the therapeutic value of EA in patients with hypertension.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mild coronary disease, and no significant ECG change reflecting ischemia at rest

Exclusion Criteria:

  • Pregnant or nursing women
  • Individuals with severe coronary disease (continuous angina)
  • Conduction abnormalities on ECG consistent with left bundle branch block
  • Cardiac arrhythmias associated with low blood pressure (90 mmHg)
  • Peripheral vascular disease
  • Orthopedic disease
  • Diabetic or psychological illness that could interfere with safe performance of exercise of psychophysiological stress testing
  • Those with known sensitivity to topical preparations or strong reactions to medical dressings and skin tapes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932139

Contacts
Contact: Peng Li, MD, LAc 949-824-6123
Contact: Sivarama Prasad Vinjamury 562-947-8755 ext 7364

Locations
United States, California
General Clinical Research Center (GCRC) Recruiting
Irvine, California, United States, 92697
Contact: Peng Li, MD, LAc    949-824-6123      
Sub-Investigator: Peng Li, MD, LAc         
Sub-Investigator: Sivarama Prasad Vinjamuary         
Sub-Investigator: Eric Hsiao, MD, PhD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Study Director: Peng Li, MD, LAc University of California, Irvine
Study Director: Sivarama Prasad Vinjamury Southern California University of Health Sciences
Study Director: Eric Hsiao, Md, PhD, LAc Southern California University of Health Sciences
  More Information

No publications provided

Responsible Party: John C Longhurst, MD, PhD, University of California Irvine
ClinicalTrials.gov Identifier: NCT00932139     History of Changes
Other Study ID Numbers: 1999-2222
Study First Received: July 1, 2009
Last Updated: October 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Hypertension
blood pressure
arrhythmias
mild to moderate hypertension (145-199/90-110)

ClinicalTrials.gov processed this record on March 03, 2015