Angina, StableASAPNCT01686230
Acupuncture in Patients With Stable Angina Pectoris
A study testing acupuncture and Basic treatment in people with Angina, Stable, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Angina, Stable
- What is being tested?
- acupuncture and Basic treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
About this study
Official title: 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.
Read the 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.
- Conditions
- Angina, Stable
- Being tested
- acupuncture, Basic treatment
- Keywords
- acupuncture, Angina, Stable Angina Pectoris
- Medical subject headings
- Angina, Stable, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called Electro-acupuncture，Massage
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。
Basic treatmentDrug
Also called health education ， basic drug therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| acupoints on specific meridian | Experimental | Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian. Receives: Other: acupuncture; Drug: Basic treatment |
| acupoints on the other meridian | Active comparator | Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。 Receives: Other: acupuncture; Drug: Basic treatment |
| sham acupoints | Sham comparator | Acupuncture plus foundation treatment。We use sham acupoints。 Receives: Other: acupuncture; Drug: Basic treatment |
| waiting-list | Other | wait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations. Receives: Drug: Basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of angina attacks
The frequency of angina attack during 4-week.
Measured: 16 weeks after inclusion
Secondary outcomes (8)
The severity of angina ( VAS score)
The VAS score evaluation angina pain severity
Measured: 0 day,4, 8, 12, 16 weeks after inclusion
The dosage of nitroglycerin
Measured: 0 day,4, 8, 12, 16 weeks after inclusion
Six minute walk test
Six minute walk test in the evaluation of exercise tolerance
Measured: 0 day and 4 weeks after inclusion
Dynamic ECG Observation of the changes of ST-T
Dynamic electrocardiogram in six minute walk test to do
Measured: 0 day and 4 weeks after inclusion
The Seattle Angina Questionnaire ( SAQ ) score
Measured: 0 day,4, 8, 12, 16 weeks after inclusion
self-rating anxiety scale
Measured: 0 day,4, 8, 16 weeks after inclusion
The incidence of cardiovascular episode during the 4 months
The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)
Measured: 4, 8, 12, 16 weeks after inclusion
Self-rating Depression Scale
Measured: 0 day,4, 8, 16 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- fan-rong liang, Professor, Study chair, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686230
- Sponsor's protocol ID
- 2012CB518501-4
- Acronym
- ASAP
- Status last verified
- Feb 2020
- First submitted
- 23 Aug 2012
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31355870Li 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.
PubMed 24499445
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture in Patients With Stable Angina Pectoris: an Open Label, Randomized, Controlled,Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT01686230
- Acronym / sponsor ID
- ASAP / 2012CB518501-4
- Conditions
- Angina, Stable
- Keywords
- acupuncture, Angina, Stable Angina Pectoris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Hunan University of Traditional Chinese Medicine
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acupoints on specific meridian | Experimental | Other: acupuncture, Drug: Basic treatmentAcupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian. |
| acupoints on the other meridian | Active comparator | Other: acupuncture, Drug: Basic treatmentAcupuncture plus foundation treatment。We choose the acupoints on the other meridian。 |
| sham acupoints | Sham comparator | Other: acupuncture, Drug: Basic treatmentAcupuncture plus foundation treatment。We use sham acupoints。 |
| waiting-list | Other | Drug: Basic treatmentwait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: Electro-acupuncture，MassageIn 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 | acupoints on specific meridian, acupoints on the other meridian, sham acupoints |
| Basic treatmentAlso: health education ， basic drug therapyEach 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. | Drug | acupoints on specific meridian, acupoints on the other meridian, sham acupoints, waiting-list |
Primary outcome
Number of angina attacks
Time frame: 16 weeks after inclusion
The frequency of angina attack during 4-week.
8 secondary outcomes
The severity of angina ( VAS score)
Time frame: 0 day,4, 8, 12, 16 weeks after inclusion
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
Dynamic ECG Observation of the changes of ST-T
Time frame: 0 day and 4 weeks after inclusion
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
Self-rating Depression Scale
Time frame: 0 day,4, 8, 16 weeks after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 31355870Zhao 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.
- Derived from this study: PubMed 24499445Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fan-rong liang, Professor study chair
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and Basic treatment in people with Angina, Stable, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of angina attacks (time frame: 16 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686230, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.