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NCT Number: NCT05482009

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

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;

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Key information

Conditions

Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, 110000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Chinese Medicine Treatment Combined with Western Medicine Basic Treatment

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Jiangsu Famous Medical Technology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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