Back to results

Acupuncture in Patients With Stable Angina Pectoris (ASAP)

Primary Purpose

Angina, Stable

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

acupuncture

Basic treatment

About this trial

This is an interventional basic science trial for Angina, Stable focused on measuring acupuncture, Angina, Stable Angina Pectoris

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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.

Sites / Locations

Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Sham Comparator

Other

Arm Label

acupoints on specific meridian

acupoints on the other meridian

sham acupoints

waiting-list

Arm Description

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

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

Acupuncture plus foundation treatment。We use sham acupoints。

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

Outcomes

Primary Outcome Measures

Number of angina attacks

The frequency of angina attack during 4-week.

Secondary Outcome Measures

The severity of angina ( VAS score)

The VAS score evaluation angina pain severity

The dosage of nitroglycerin

Six minute walk test

Six minute walk test in the evaluation of exercise tolerance

Dynamic ECG Observation of the changes of ST-T

Dynamic electrocardiogram in six minute walk test to do

The Seattle Angina Questionnaire ( SAQ ) score

self-rating anxiety scale

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)

Self-rating Depression Scale

Full Information

NCT ID

NCT01686230

First Posted

August 23, 2012

Last Updated

February 13, 2020

Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

Hunan University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01686230

Brief Title

Acupuncture in Patients With Stable Angina Pectoris

Acronym

ASAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

July 2012 (Actual)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu University of Traditional Chinese Medicine

Collaborators

Hunan University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina, Stable

Keywords

acupuncture, Angina, Stable Angina Pectoris

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

404 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acupoints on specific meridian

Arm Type

Experimental

Arm Description

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

Arm Title

acupoints on the other meridian

Arm Type

Active Comparator

Arm Description

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

Arm Title

sham acupoints

Arm Type

Sham Comparator

Arm Description

Acupuncture plus foundation treatment。We use sham acupoints。

Arm Title

waiting-list

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

acupuncture

Other Intervention Name(s)

Electro-acupuncture，Massage

Intervention Description

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。

Intervention Type

Drug

Intervention Name(s)

Basic treatment

Other Intervention Name(s)

health education ， basic drug therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of angina attacks

Description

The frequency of angina attack during 4-week.

Time Frame

16 weeks after inclusion

Secondary Outcome Measure Information:

Title

The severity of angina ( VAS score)

Description

The VAS score evaluation angina pain severity

Time Frame

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

Title

The dosage of nitroglycerin

Time Frame

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

Title

Six minute walk test

Description

Six minute walk test in the evaluation of exercise tolerance

Time Frame

0 day and 4 weeks after inclusion

Title

Dynamic ECG Observation of the changes of ST-T

Description

Dynamic electrocardiogram in six minute walk test to do

Time Frame

0 day and 4 weeks after inclusion

Title

The Seattle Angina Questionnaire ( SAQ ) score

Time Frame

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

Title

self-rating anxiety scale

Time Frame

0 day,4, 8, 16 weeks after inclusion

Title

The incidence of cardiovascular episode during the 4 months

Description

The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)

Time Frame

4, 8, 12, 16 weeks after inclusion

Title

Self-rating Depression Scale

Time Frame

0 day,4, 8, 16 weeks after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

fan-rong liang, Professor

Organizational Affiliation

Chengdu University of Traditional Chinese Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Chengdu University of Traditional Chinese Medicine

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610075

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

31355870

Citation

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.

Results Reference

derived

PubMed Identifier

24499445

Citation

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.

Results Reference

derived

Learn more about this trial

Acupuncture in Patients With Stable Angina Pectoris

We'll reach out to this number within 24 hrs