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Angina PectorisNCT05482009

Treatment of Angina Pectoris After Coronary Revascularization With Integrated Traditional Chinese and Western Medicine

An observational study of Angina Pectoris, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study used a multicenter, prospective cohort study. According to whether they received TCM treatment and the degree of exposure to TCM, the cohorts were divided into strong TCM exposure group, TCM exposure group, weak TCM exposure group and Western medicine exposure group. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Angina Pectoris
What is being tested?
Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment
Type of treatment
Injection or infusion
How many people
2,000 participants
Where
1 siteChina
Study dates
1 Jun 2019to 30 Jun 2022
Phase
Observational
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients in tertiary hospitals

Who may be able to join

  • ①Age ≥18 years old and ≤85 years old;
  • Patients who have undergone coronary revascularization (including coronary bypass and/or PCI) in the past.
  • Those who participated voluntarily and signed the informed consent form.

Who cannot join

  • ①Incomplete case data, unable to provide original surgical data entry;
  • Patients who meet the diagnostic criteria for coronary heart disease, angina pectoris or myocardial infarction, but have not undergone coronary revascularization or failed surgery;
  • Patients who still need continuous mechanical adjuvant therapy after successful coronary revascularization; ④ Combined with other heart diseases, such as malignant arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia), or cardiac insufficiency before and after surgery (cardiac function class IV, NYHA class or Killip class), severe cardiopulmonary insufficiency .
  • Those who have a history of hemorrhagic cerebrovascular accident, or a history of ischemic cerebrovascular accident (including TIA) within half a year; ⑥Mental patients or those who may not be able to cooperate with the program requirements and follow-up procedures due to educational level, language barriers and other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning, 110000

Other trials in China

About this study

Official title: Evidence-based Optimization of Chinese and Western Medicine Differentiation and Treatment Scheme for Angina Pectoris After Coronary Revascularization

This study used a multicenter, prospective cohort study. According to whether they received TCM treatment and the degree of exposure to TCM, the cohorts were divided into strong TCM exposure group, TCM exposure group, weak TCM exposure group and Western medicine exposure group. The first three groups received traditional Chinese medicine treatment combined with western medicine basic treatment, and the cumulative treatment time of traditional Chinese medicine reached 80%, 30%-79% or 30% of the total course of treatment, respectively. The fourth group received basic western medicine treatment alone. Among them, Chinese medicines (including Chinese patent medicines, Chinese medicine decoctions, Chinese medicine granules, and Chinese medicine injections) have been used and/or taken for a total of 5 months;

Read the detailed description

The purpose of this study was to observe whether the combination of traditional Chinese medicine intervention on the basis of standardized western medicine treatment could further reduce the incidence of cardiovascular events in patients with angina pectoris after coronary revascularization compared with western medicine treatment, and to conduct objective follow-up. Evaluation of integrated Chinese and Western medicine interventions. Clinical efficacy of angina pectoris after coronary revascularization and characteristic advantages of TCM syndrome improvement.

The trial is a multicenter, prospective clinical cohort study design. It is expected that 2,000 subjects will be included, and they will be divided into 4 groups according to whether they receive Chinese medicine treatment and the degree of exposure to Chinese medicine. One group received only western medicine basic treatment, and the other three groups received Chinese medicine treatment combined with western medicine basic treatment (the difference was that the cumulative treatment time of Chinese medicine reached 80%, 30%-79% or 30% of the total course of treatment, respectively). Among them, Chinese medicines (including Chinese patent medicines, Chinese medicine decoctions, Chinese medicine granules, and Chinese medicine injections) have been used and/or taken for 5 months in total.

The duration of treatment (including follow-up) in this trial was 24 months. Study data were recorded at 0, 3, 6, 9, 12, 15, 18, 21, and 24 months.

Conditions
Angina Pectoris
Being tested
Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment
Keywords
Integrated Chinese and Western Medicine Treatment, Comprehensive Treatment
Medical subject headings
Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional Chinese Medicine Treatment Combined with Western Medicine Basic TreatmentOther

    The cumulative observation and treatment (including Chinese patent medicine, Chinese medicine decoction, Chinese medicine granule, Chinese medicine injection, and western medicine) were more than 5 months, and the follow-up was 1.5 years.

Study groups in NCT05482009
Study groupRoleWhat they receive
Strong exposure group of traditional Chinese medicinereceiving traditional Chinese medicine treatment + basic western medicine treatment, the cumulative time of traditional Chinese medicine treatment reaches more than 80% of the total course of treatment
Receives: Other: Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment
Moderate Chinese medicine exposure groupreceived Chinese medicine treatment + western medicine basic treatment, the cumulative time of Chinese medicine treatment reached 30%-79% of the total course of treatment
Receives: Other: Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment
Weak exposure group of traditional Chinese medicinereceiving traditional Chinese medicine treatment + basic western medicine treatment, the cumulative time of traditional Chinese medicine treatment is less than 30% of the total course of treatment
Receives: Other: Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment
Western medicine groupreceive basic western medicine treatment only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of MACE

    Major adverse cardiovascular events that may have occurred in subjects were recorded throughout the trial,and assessed 24 months after taking medicine.

    Measured: Assess once 24 months after taking medicine

  2. Readmission rate

    Readmissions for cardiovascular disease were recorded throughout the trial,and assessed 24 months after taking medicine.

    Measured: Assess once 24 months after taking medicine

Secondary outcomes (9)

  1. Angina attack frequency scale

    Subjects were assessed using the Angina attack frequency scale at months 3, 6, 9, 12, 15, 18, 21, and 24. The minimum value is 0 and the maximum value is 6. Higher scores indicate worse subjects.

    Measured: 3 months

  2. Angina Attack Duration scale

    Subjects were assessed using the Angina Attack Duration scale at months3, 6, 9, 12, 15, 18, 21, and 24. The minimum value is 0 and the maximum value is 6. Higher scores indicate worse subjects.

    Measured: 3 months

  3. Angina Pain scale

    Subjects were assessed using the Angina Pain scale at months 3, 6, 9, 12, 15, 18, 21, and 24. The minimum value is 0 and the maximum value is 6. Higher scores indicate worse subjects.

    Measured: 3 months

  4. Nitroglycerin Dosage scale

    Subjects were assessed using the Nitroglycerin Dosage scale at months 3, 6, 9, 12, 15, 18, 21, and 24. The minimum value is 0 and the maximum value is 6. Higher scores indicate worse subjects.

    Measured: 3 months

  5. The Seattle angina questionaire

    Subjects were assessed using the Seattle Angina Questionnaire at months 0, 3, 6, 9, 12, 15, 18, 21, and 24. The minimum value is 0 and the maximum value is 100. Higher scores indicate better subjects.

    Measured: 3 months

  6. NYHA classification

    Subjects were assessed at 0, 3, 6, 9, 12, 15, 18, 21, and 24 months using NYHA classification. Results include grades I, II, III, and IV.Higher Class indicate worse subjects.

    Measured: 3 months

  7. Traditional Chinese medicine syndrome rating scale

    On the 0th, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th months, the subjects were evaluated using the TCM syndrome score table, and the evaluation results were judged as markedly effective, effective, ineffective or aggravated.

    Measured: 3 months

  8. Patient Health Questionaire-9 scale

    On the 0th, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th months,Subjects were assessed using the Patient Health Questionaire-9 scale with a minimum of 0 and a maximum of 27. Higher scores indicate worse subjects.

    Measured: 3 months

  9. Generalized Anxiety Disorder -7 scale

    On the 0th, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th months,Subjects were assessed using theGeneralized Anxiety Disorder -7 scale with a minimum of 0 and a maximum of 21. Higher scores indicate worse subjects.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start1 Jun 2019
  3. Primary completion31 Dec 2021
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05482009
Sponsor's protocol ID
002-20190701
Status last verified
Jul 2022
First submitted
25 Jul 2022
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Angina Pectoris, run by Jiangsu Famous Medical Technology Co., Ltd. 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 3 inclusion and 4 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 1 Aug 2022. 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. 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?

Incidence of MACE (time frame: Assess once 24 months after taking medicine). The study lists 2 primary outcomes in all. 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 NCT05482009.

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 1 Aug 2022.

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