Bidirectional Cohort Study on Improvement of Quality of Life in Patients After Coronary Intervention With Kuanxiong Aerosol
NCT Number: NCT06480097
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Angina Pectoris|Kuanzhong Aerosol|Quality of Life|Cardiac Function
Sponsor: Nanfang Hospital, Southern Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-01
Completion Date: 2024-09-28
Locations: Nanfang hospital, Southern medical university, Guangzhou, Guangdong, 510515, China

Summary:
The goal of this observational study is to compare in patients with Angina Pectoris after PCI for Coronary Heart Disease. The main questions it aims to answer are:

* To evaluate the effect of Kuanxiong Aerosol on the quality of life of patients with angina pectoris after PCI for Coronary Heart Disease.
* To evaluate the effect of Kuanxiong Aerosol on relieving angina pectoris and improving cardiac function.

The comparison group will received routine treatment .The experimental group will received sublingual spray of Kuanxiong Aerosol on the basis of routine treatment，two sprays per time，three times a day, for a continuous month. After 1 month of treatment, the quality of life, the improvement of cardiac function and the relief of angina pectoris were compared between the two groups. Researchers will compare two groups to see if Kuanxiong Aerosol can improve the quality of life, cardiac function, and reduce the frequency and duration of angina pectoris in patients with angina pectoris after PCI.

Primary Outcome Measures: The improvement of quality of life in two groups after one month of treatment, Compare the changes in SF-36 scores before and after treatment between two groups of patients. SF-36 consists of 9 dimensions and 36 items: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health Perception (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), and Mental Health (MH). SF-36 can be self-administered, interviewer-administered, or conducted via telephone inquiry. The main statistical indicator for SF-36 is calculating the health scores for the eight dimensions. Based on the rescaled values of each item within each dimension, initial and final scores can be calculated for these eight dimensions. The scoring method involves summing up the weighted scores of individual items within each dimension to obtain a raw score for that dimension, which is then converted into a standardized score ranging from 0 to 100. Higher scale scores indicate better quality of life., Baseline and 1 months.
Secondary Outcome Measures: The relief of angina pectoris and the improvement of cardiac function in the two groups after one month of treatment, (1)The Seattle Angina Questionnaire (SAQ) is a self-administered,disease-specific measure of angina severity. The SAQ quantifies patients'physical limitations causedby angina, the frequency of and recent changes intheir symptoms, their satisfaction with treatment,and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate betterfunction (e.g., less physical limitation, less angina,and better quality of life) . The Seattle Angina Questionnaire summary score averages the domains of angina limitation, frequency, and quality of life to provide an overall metric of angina severity. (2)Indicators related to cardiac function include serum N-terminal pro-brain natriuretic peptide, left ventricular ejection fraction(LVEF), left ventricular end-diastolic diameter(LVEDD), and 6-minute walking distance. Both LVEF and LVEDD are obtained through cardiac color Doppler ultrasound examination., Baseline and 1 months.