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

July 28, 2022 updated by: Jiangsu Famous Medical Technology Co., Ltd.

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;

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in tertiary hospitals

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Strong exposure group of traditional Chinese medicine
receiving 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
Other: Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment
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.
Moderate Chinese medicine exposure group
received Chinese medicine treatment + western medicine basic treatment, the cumulative time of Chinese medicine treatment reached 30%-79% of the total course of treatment
Other: Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment
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.
Weak exposure group of traditional Chinese medicine
receiving 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
Other: Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment
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.
Western medicine group
receive basic western medicine treatment only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of MACE
Time Frame: Assess once 24 months after taking medicine
Major adverse cardiovascular events that may have occurred in subjects were recorded throughout the trial,and assessed 24 months after taking medicine.
Assess once 24 months after taking medicine
Readmission rate
Time Frame: Assess once 24 months after taking medicine
Readmissions for cardiovascular disease were recorded throughout the trial,and assessed 24 months after taking medicine.
Assess once 24 months after taking medicine

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Angina attack frequency scale
Time Frame: 3 months
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.
3 months
Angina Attack Duration scale
Time Frame: 3 months
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.
3 months
Angina Pain scale
Time Frame: 3 months
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.
3 months
Nitroglycerin Dosage scale
Time Frame: 3 months
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.
3 months
The Seattle angina questionaire
Time Frame: 3 months
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.
3 months
NYHA classification
Time Frame: 3 months
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.
3 months
Traditional Chinese medicine syndrome rating scale
Time Frame: 3 months
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.
3 months
Patient Health Questionaire-9 scale
Time Frame: 3 months
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.
3 months
Generalized Anxiety Disorder -7 scale
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Famous Medical Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shuai Wang, master, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 002-20190701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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