Acupuncture in Patients With Stable Angina Pectoris

NCT01686230 | Completed DMC

• 1 other identifier: 2012CB518501-4
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and waiting-list. And to confirm the specificity of acupoints on meridian.

Conditions

Angina, Stable

Keywords

acupuncture; Angina; Stable Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Number of angina attacks

  The frequency of angina attack during 4-week.

  16 weeks after inclusion

Secondary Outcomes (8)

• The severity of angina ( VAS score)

  0 day,4, 8, 12, 16 weeks after inclusion

• The dosage of nitroglycerin

  0 day,4, 8, 12, 16 weeks after inclusion

• Six minute walk test

  0 day and 4 weeks after inclusion

• Dynamic ECG Observation of the changes of ST-T

  0 day and 4 weeks after inclusion

• The Seattle Angina Questionnaire ( SAQ ) score

  0 day,4, 8, 12, 16 weeks after inclusion

Study Arms (4)

acupoints on specific meridian

EXPERIMENTAL

Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.

Other: acupuncture; Drug: Basic treatment

acupoints on the other meridian

ACTIVE COMPARATOR

Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。

Other: acupuncture; Drug: Basic treatment

sham acupoints

SHAM COMPARATOR

Acupuncture plus foundation treatment。We use sham acupoints。

Other: acupuncture; Drug: Basic treatment

waiting-list

OTHER

wait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations.

Drug: Basic treatment

Interventions

acupuncture OTHER

In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。

Also known as: Electro-acupuncture，Massage

acupoints on specific meridian; acupoints on the other meridian; sham acupoints

Basic treatment DRUG

Each group in the basic treatment，Foundation treatment including health education and basic drug therapy. We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc. Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

Also known as: health education ， basic drug therapy

acupoints on specific meridian; acupoints on the other meridian; sham acupoints; waiting-list

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria of ACC/AHA angina pectoris of coronary heart disease.
• ≤ age ≤ 80 years of age, both male and female.
• The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.
• Patients signed the informed consent.

You may not qualify if:

• age≤35 or age≥80
• Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
• Combined with cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system, severe primary disease clinical failed to effectively control the disease.
• Complicated with mental disorders.
• allergic constitution or bleeding disorder.
• Patients accompany with acute coronary syndrome (including acute myocardial infarction, unstable angina), severe arrhythmias ( severe atrioventricular block, ventricular tachycardia, heartbeat influence the flow dynamics in supraventricular tachycardia, heartbeat frequent premature beats especially premature ventricular contractions ), atrial fibrillation, primary cardiomyopathy, valvular heart disease.
• The blood pressure and blood glucose fail to meet the treatment targets.
• Cardiovascular disease who had been treated with acupuncture during the previous three months.
• Currently participating in other clinical trials.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead
• Hunan University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

Related Publications (2)

• Zhao L, Li D, Zheng H, Chang X, Cui J, Wang R, Shi J, Fan H, Li Y, Sun X, Zhang F, Wu X, Liang F. Acupuncture as Adjunctive Therapy for Chronic Stable Angina: A Randomized Clinical Trial. JAMA Intern Med. 2019 Oct 1;179(10):1388-1397. doi: 10.1001/jamainternmed.2019.2407.

  PMID: 31355870 DERIVED

• Li D, Yang M, Zhao L, Zheng H, Li Y, Chang X, Cui J, Wang R, Shi J, Lv J, Leng J, Li J, Liang F. Acupuncture for chronic, stable angina pectoris and an investigation of the characteristics of acupoint specificity: study protocol for a multicenter randomized controlled trial. Trials. 2014 Feb 5;15:50. doi: 10.1186/1745-6215-15-50.

  PMID: 24499445 DERIVED

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• fan-rong liang, Professor

  Chengdu University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: September 17, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)