Clinical trial NCT01686230: Acupuncture in Patients With Stable Angina Pectoris
Official title: Effect of Acupuncture in Patients With Stable Angina Pectoris: an Open Label, Randomized, Controlled,Multi-center Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina, Stable
Keywords: acupuncture
Angina
Stable Angina Pectoris
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Hunan University of Traditional Chinese Medicine
First posted: 2012-09-17
Enrollment: 404
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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:

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.

Primary outcomes:
measure: Number of angina attacks
timeFrame: 16 weeks after inclusion
Secondary outcomes:
measure: The severity of angina ( VAS score)
timeFrame: 0 day,4, 8, 12, 16 weeks after inclusion
measure: The dosage of nitroglycerin
timeFrame: 0 day,4, 8, 12, 16 weeks after inclusion
measure: Six minute walk test
timeFrame: 0 day and 4 weeks after inclusion
measure: Dynamic ECG Observation of the changes of ST-T
timeFrame: 0 day and 4 weeks after inclusion
measure: The Seattle Angina Questionnaire ( SAQ ) score
timeFrame: 0 day,4, 8, 12, 16 weeks after inclusion
measure: self-rating anxiety scale
timeFrame: 0 day,4, 8, 16 weeks after inclusion
measure: The incidence of cardiovascular episode during the 4 months
timeFrame: 4, 8, 12, 16 weeks after inclusion
measure: Self-rating Depression Scale
timeFrame: 0 day,4, 8, 16 weeks after inclusion
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: fan-rong liang, Professor
role: STUDY_CHAIR
References:
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.
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.