Acupuncture in Patients With Stable Angina Pectoris (ASAP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Angina, Stable |
Other: acupuncture Drug: Basic treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effect of Acupuncture in Patients With Stable Angina Pectoris: an Open Label, Randomized, Controlled,Multi-center Clinical Study |
- Number of angina attacks [ Time Frame: 16 weeks after inclusion ] [ Designated as safety issue: No ]The frequency of angina attack during 4-week.
- The severity of angina ( VAS score) [ Time Frame: 0 day,4, 8, 12, 16 weeks after inclusion ] [ Designated as safety issue: No ]The VAS score evaluation angina pain severity
- The dosage of nitroglycerin [ Time Frame: 0 day,4, 8, 12, 16 weeks after inclusion ] [ Designated as safety issue: No ]
- Six minute walk test [ Time Frame: 0 day and 4 weeks after inclusion ] [ Designated as safety issue: No ]Six minute walk test in the evaluation of exercise tolerance
- Dynamic ECG Observation of the changes of ST-T [ Time Frame: 0 day and 4 weeks after inclusion ] [ Designated as safety issue: No ]Dynamic electrocardiogram in six minute walk test to do
- The Seattle Angina Questionnaire ( SAQ ) score [ Time Frame: 0 day,4, 8, 12, 16 weeks after inclusion ] [ Designated as safety issue: No ]
- self-rating anxiety scale [ Time Frame: 0 day,4, 8, 16 weeks after inclusion ] [ Designated as safety issue: No ]
- The incidence of cardiovascular episode during the 4 months [ Time Frame: 4, 8, 12, 16 weeks after inclusion ] [ Designated as safety issue: Yes ]The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)
- Self-rating Depression Scale [ Time Frame: 0 day,4, 8, 16 weeks after inclusion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 404 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: health education ， basic drug therapy
|
|
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 Name: health education ， basic drug therapy
|
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| Ages Eligible for Study: | 35 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: fan-rong liang, professor | 0086-13438151411 | acuresearch@126.com |
| China, Sichuan | |
| Chengdu University of Traditional Chinese Medicine | Recruiting |
| Chengdu, Sichuan, China, 610075 | |
| Contact: hui zhen, doctor 0086-13518137928 30103752@qq.com | |
| Contact: de-hua h li, doctor 0086-18980079361 si_ff@163.com | |
| Study Chair: | fan-rong liang, Professor | Chengdu University of Traditional Chinese Medicine |
More Information
No publications provided
| Responsible Party: | Chengdu University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01686230 History of Changes |
| Other Study ID Numbers: | 2012CB518501-4 |
| Study First Received: | August 23, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | China: Ministry of Science and Technology United States: Food and Drug Administration |
Keywords provided by Chengdu University of Traditional Chinese Medicine:
|
acupuncture Angina Stable Angina Pectoris |
Additional relevant MeSH terms:
|
Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013