Percutaneous Coronary InterventionNCT03789344
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI
A study testing acupuncture and Psychotherapy in people with Percutaneous Coronary Intervention, run by Huan Wang, MD at 1 site in China.
Trial summary
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated with PCI Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- acupuncture and Psychotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Dec 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria were patients who underwent coronary angiography. Patients suffer from Generalized anxiety disorder(GOD).
Who cannot join
- The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PLA General Hospital
Beijing, Beijing Municipality, 100853
Huan Wang, M.D., +8610-66876049, wanghuan_yy@163.com
Huan Wang, M.D.
About this study
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated with PCI
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- acupuncture, Psychotherapy, blank control
- Keywords
- acupuncture, PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.
PsychotherapyOther
Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.
blank controlOther
Blank control subjects would be observed only during this investigation.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture treatment | Experimental | Not described Receives: Other: acupuncture |
| Psychotherapy | Active comparator | Not described Receives: Other: Psychotherapy |
| blank control | Placebo comparator | Not described Receives: Other: blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Heart Rate Variability at 7 days
The primary efficacy variable was the heart rate variability of patients accepted the PCI treatment between control group
Measured: at 1day before and 7 days after percutaneous coronary intervention
Secondary outcomes (3)
Scores of HAM-A
scores of HAM-A were recorded on 1day before, 7，14 days after the intervene
Measured: 1day before, 7，14 days after the intervene
Scores of AIS
scores of AIS were recorded on 1day before, 7，14 days
Measured: 1day before, 7，14 days after the intervene
Scores of HRSD
scores of HRSD were recorded on 1day before, 7，14 days
Measured: 1day before, 7，14 days after the intervene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Dec 2018
- Primary completion1 May 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huan Wang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huan Wang, MD, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789344
- Sponsor's protocol ID
- 301FW
- Status last verified
- Dec 2018
- First submitted
- 24 Dec 2018
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pei JH, Gan F, Bai YH, Xing YL, Jia JJ, Wang H. Instant and short-term effects of acupuncture for depression and anxiety in unstable angina pectoris patients with percutaneous coronary interventions. Front Cardiovasc Med. 2024 Jan 19;11:1173080. doi: 10.3389/fcvm.2024.1173080. eCollection 2024.
PubMed 38312234
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI
- ClinicalTrials.gov ID
- NCT03789344
- Acronym / sponsor ID
- 301FW
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- acupuncture, PCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Huan Wang, MDUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 28 Dec 2018 (actual)
- 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.
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated with PCI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture treatment | Experimental | Other: acupuncture |
| Psychotherapy | Active comparator | Other: Psychotherapy |
| blank control | Placebo comparator | Other: blank control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The main inclusion criteria were patients who underwent coronary angiography. Patients suffer from Generalized anxiety disorder(GOD).
Key exclusion criteria (1 listed)
- The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.
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 |
|---|---|---|
| acupunctureAcupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day. | Other | Acupuncture treatment |
| PsychotherapySubjects in psychotherapy group would be accepted 20mins- psychotherapy per day. | Other | Psychotherapy |
| blank controlBlank control subjects would be observed only during this investigation. | Other | blank control |
Primary outcome
Change from Baseline Heart Rate Variability at 7 days
Time frame: at 1day before and 7 days after percutaneous coronary intervention
The primary efficacy variable was the heart rate variability of patients accepted the PCI treatment between control group
3 secondary outcomes
Scores of HAM-A
Time frame: 1day before, 7，14 days after the intervene
Scores of AIS
Time frame: 1day before, 7，14 days after the intervene
Scores of HRSD
Time frame: 1day before, 7，14 days after the intervene
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Derived from this study: PubMed 38312234Pei JH, Gan F, Bai YH, Xing YL, Jia JJ, Wang H. Instant and short-term effects of acupuncture for depression and anxiety in unstable angina pectoris patients with percutaneous coronary interventions. Front Cardiovasc Med. 2024 Jan 19;11:1173080. doi: 10.3389/fcvm.2024.1173080. eCollection 2024.
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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.
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 Psychotherapy in people with Percutaneous Coronary Intervention, run by Huan Wang, MD 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Dec 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Heart Rate Variability at 7 days (time frame: at 1day before and 7 days after percutaneous coronary intervention). 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 NCT03789344, which also lists 1 linked publication.
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 28 Dec 2018.