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Completed

NCT Number: NCT01686230

Acupuncture in Patients With Stable Angina Pectoris

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.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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。

Other names: Electro-acupuncture,Massage

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.

Other names: health education , basic drug therapy

Primary outcomes

  1. Number of angina attacks

    Time frame: 16 weeks after inclusion

    The frequency of angina attack during 4-week.

Secondary outcomes

  1. The severity of angina ( VAS score)

    Time frame: 0 day,4, 8, 12, 16 weeks after inclusion

    The VAS score evaluation angina pain severity

  2. The dosage of nitroglycerin

    Time frame: 0 day,4, 8, 12, 16 weeks after inclusion

  3. Six minute walk test

    Time frame: 0 day and 4 weeks after inclusion

    Six minute walk test in the evaluation of exercise tolerance

  4. Dynamic ECG Observation of the changes of ST-T

    Time frame: 0 day and 4 weeks after inclusion

    Dynamic electrocardiogram in six minute walk test to do

  5. The Seattle Angina Questionnaire ( SAQ ) score

    Time frame: 0 day,4, 8, 12, 16 weeks after inclusion

  6. self-rating anxiety scale

    Time frame: 0 day,4, 8, 16 weeks after inclusion

  7. The incidence of cardiovascular episode during the 4 months

    Time frame: 4, 8, 12, 16 weeks after inclusion

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

  8. Self-rating Depression Scale

    Time frame: 0 day,4, 8, 16 weeks after inclusion

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Collaborators

  • Hunan University of Traditional Chinese Medicine

Registry information

Official study title

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

Acronym: ASAP

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2012
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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