Effect of Electro-Acupuncture on Blood Pressure - Full Text View

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00932139

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Neural Mechanism of the Effect of Acupuncture on Myocardial Ischemia

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Acupuncture Arrhythmia High Blood Pressure

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:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Blood Pressure: Experimental 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.

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

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

Contacts

Contact: Peng Li, MD, LAc	949-824-6123
Contact: Sivarama Prasad Vinjanury	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 Vinjanuary
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 Vinjanury	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:	University of California Irvine ( John C Longhurst, MD, PhD )
Study ID Numbers:	1999-2222
Study First Received:	July 1, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00932139 History of Changes
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)

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Arrhythmias, Cardiac
Hypertension

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Vascular Diseases

Cardiovascular Diseases
Hypertension
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 10, 2009