Acupuncture in Patients With Stable Angina Pectoris (ASAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chengdu University of Traditional Chinese Medicine
Sponsor:
Collaborator:
Hunan University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01686230
First received: August 23, 2012
Last updated: March 26, 2013
Last verified: March 2013
  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

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Number of angina attacks [ Time Frame: 16 weeks after inclusion ] [ Designated as safety issue: No ]
    The frequency of angina attack during 4-week.


Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686230

Contacts
Contact: fan-rong liang, professor 0086-13438151411 acuresearch@126.com

Locations
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   
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Hunan University of Traditional Chinese Medicine
Investigators
Study Chair: fan-rong liang, Professor Chengdu University of Traditional Chinese Medicine
  More Information

No publications provided by Chengdu University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014