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

NCT05482009 | Completed

• 1 other identifier: 002-20190701
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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;

Conditions

Angina Pectoris

Keywords

Integrated Chinese and Western Medicine Treatment; Comprehensive Treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  Assess once 24 months after taking medicine

• Readmission rate

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

  Assess once 24 months after taking medicine

Secondary Outcomes (9)

• Angina attack frequency scale

  3 months

• Angina Attack Duration scale

  3 months

• Angina Pain scale

  3 months

• Nitroglycerin Dosage scale

  3 months

• The Seattle angina questionaire

  3 months

Study Arms (4)

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

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

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

Western medicine group

receive basic western medicine treatment only

Interventions

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.

Moderate Chinese medicine exposure group; Strong exposure group of traditional Chinese medicine; Weak exposure group of traditional Chinese medicine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in tertiary hospitals

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

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

Study Officials

• Shuai Wang, master

  Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 1, 2022
• Study Start: June 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

CN (1)