Acupuncture in Patients With Stable Angina Pectoris (ASAP)

Effect of Acupuncture in Patients With Stable Angina Pectoris: an Open Label, Randomized, Controlled,Multi-center Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Angina, Stable
• Intervention / Treatment: Other: acupuncture; Drug: Basic treatment

Detailed Description

The basis of acupuncture is the theory of meridians and acupoints. Meridian and collaterals internally pertain to viscera, and externally spread over the extremities. An acupoint is the place where the visceral qi and meridian qi distributed in. besides acupoints are the stimulus points and reactive points for acupuncture to treat the diseases. Selecting the acupoints on the specific meridian is the basic principle of acupuncture. Recently, as to the existence of specificity of acupoints on the meridian has been questioned by many researchers. This trial using chronic stable angina pectoris as a carrier, select the acupoints on the hand shao yin heart meridian and hand jue yin pericardium meridian to treat chronic stable angina pectoris. Compared with acupoints on the other meridian and non-acupoints ,aiming to evaluate the efficacy, furthermore ,to confirm the existence of the specificity of acupoints on meridian.

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1.Meet the diagnostic criteria of ACC/AHA angina pectoris of coronary heart disease.

2.35 ≤ age ≤ 80 years of age, both male and female.

3.The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.

4.Patients signed the informed consent.

Exclusion Criteria:

1. age≤35 or age≥80
2. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
3. Combined with cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system, severe primary disease clinical failed to effectively control the disease.
4. Complicated with mental disorders.
5. allergic constitution or bleeding disorder.
6. 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.
7. The blood pressure and blood glucose fail to meet the treatment targets.
8. Cardiovascular disease who had been treated with acupuncture during the previous three months.
9. Currently participating in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupoints on specific meridian; Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.	Other: acupuncture; 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。; Other Names: Electro-acupuncture，Massage; Drug: Basic treatment; 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.; Other Names: health education ， basic drug therapy
Active Comparator: acupoints on the other meridian; Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。	Other: acupuncture; 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。; Other Names: Electro-acupuncture，Massage; Drug: Basic treatment; 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.; Other Names: health education ， basic drug therapy
Sham Comparator: sham acupoints; Acupuncture plus foundation treatment。We use sham acupoints。	Other: acupuncture; 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。; Other Names: Electro-acupuncture，Massage; Drug: Basic treatment; 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.; Other Names: health education ， basic drug therapy
Other: waiting-list; wait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations.	Drug: Basic treatment; 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.; Other Names: health education ， basic drug therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of angina attacks	The frequency of angina attack during 4-week.	16 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of angina ( VAS score)	The VAS score evaluation angina pain severity	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	Six minute walk test in the evaluation of exercise tolerance	0 day and 4 weeks after inclusion
Dynamic ECG Observation of the changes of ST-T	Dynamic electrocardiogram in six minute walk test to do	0 day and 4 weeks after inclusion
The Seattle Angina Questionnaire ( SAQ ) score		0 day,4, 8, 12, 16 weeks after inclusion
self-rating anxiety scale		0 day,4, 8, 16 weeks after inclusion
The incidence of cardiovascular episode during the 4 months	The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)	4, 8, 12, 16 weeks after inclusion
Self-rating Depression Scale		0 day,4, 8, 16 weeks after inclusion

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Collaborators: Hunan University of Traditional Chinese Medicine
• Investigators: Study Chair: fan-rong liang, Professor, Chengdu University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimate): September 17, 2012

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Angina; acupuncture; Stable Angina Pectoris
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: 2012CB518501-4