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Acupuncture in Patients With Stable Angina Pectoris (ASAP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Chengdu University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686230
First Posted: September 17, 2012
Last Update Posted: September 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hunan University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
August 23, 2012
September 17, 2012
September 9, 2014
July 2012
July 2017   (Final data collection date for primary outcome measure)
Number of angina attacks [ Time Frame: 16 weeks after inclusion ]
The frequency of angina attack during 4-week.
Same as current
Complete list of historical versions of study NCT01686230 on ClinicalTrials.gov Archive Site
  • The severity of angina ( VAS score) [ Time Frame: 0 day,4, 8, 12, 16 weeks after inclusion ]
    The VAS score evaluation angina pain severity
  • The dosage of nitroglycerin [ Time Frame: 0 day,4, 8, 12, 16 weeks after inclusion ]
  • Six minute walk test [ Time Frame: 0 day and 4 weeks after inclusion ]
    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 ]
    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 ]
  • self-rating anxiety scale [ Time Frame: 0 day,4, 8, 16 weeks after inclusion ]
  • 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)
  • Self-rating Depression Scale [ Time Frame: 0 day,4, 8, 16 weeks after inclusion ]
Same as current
Not Provided
Not Provided
 
Acupuncture in Patients With Stable Angina Pectoris
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Angina, Stable
  • 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
  • Experimental: acupoints on specific meridian
    Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.
    Interventions:
    • Other: acupuncture
    • Drug: Basic treatment
  • Active Comparator: acupoints on the other meridian
    Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。
    Interventions:
    • Other: acupuncture
    • Drug: Basic treatment
  • Sham Comparator: sham acupoints
    Acupuncture plus foundation treatment。We use sham acupoints。
    Interventions:
    • Other: acupuncture
    • Drug: Basic treatment
  • waiting-list
    wait for the treatment,Only basic treatment, We will not treat the participants until they complete all the observations.
    Intervention: Drug: Basic treatment
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
404
July 2017
July 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01686230
2012CB518501-4
Yes
Not Provided
Not Provided
Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
Hunan University of Traditional Chinese Medicine
Study Chair: fan-rong liang, Professor Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP