Clinical trial NCT06480097: Bidirectional Cohort Study on Improvement of Quality of Life in Patients After Coronary Intervention With Kuanxiong Aerosol
Official title: Bidirectional Cohort Study on Improvement of Quality of Life in Patients After Coronary Intervention With Kuanxiong Aerosol
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Angina Pectoris
Kuanzhong Aerosol
Quality of Life
Cardiac Function
Keywords: quality of life
Kuanxiong Aerosol
angina pectoris
Cardiac function
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population was patients diagnosed with coronary heart disease who still had angina after PCI surgery in the Department of Cardiovascular Medicine, Nanfang Hospital, Southern Medical University from 2019 to 2023

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for coronary heart disease
* Age 18\~80 years old, male and female, lower limbs can move freely
* Patients with coronary angiography or coronary CT angiography indicating that the rate of coronary artery large vessel stenosis is greater than 80%
* Patients with angina pectoris (angina pectoris frequency ≥3 times/week) after PCI according to the judgment of the treating physician
* According to the doctor\&#39;s judgment, patients who need to use conventional drugs (ACEI/ARB, β-blockers), and patients who need to use Kuanxiong Aerosol drugs on the basis of conventional drug therapy
* Patients voluntarily sign informed consent

Exclusion Criteria:

* Allergic to ingredients contained in Kuanxiong Aerosol
* Coronary artery bypass grafting was prepared during the trial
* Blood lipid and uric acid exceeding 1.5 times the upper limit of normal reference value; Uncontrolled severe hypertension with systolic blood pressure \&gt;180mmHg and/or diastolic blood pressure \&gt;110mmHg
* severe hepatic and renal insufficiency (ALT, AST or TBIL\&gt;1.5 times the upper limit of normal reference value, Cr \&gt;1.5 times the upper limit of normal reference value)
* Malignant tumors
* Severe arrhythmias (such as rapid atrial fibrillation, ventricular tachycardia, high atrioventricular block, etc.)
* Women who are pregnant or trying to become pregnant
* The researcher judged that it is not suitable to participate in this study

Primary outcomes:
measure: The improvement of quality of life in two groups after one month of treatment
timeFrame: Baseline and 1 months.
Secondary outcomes:
measure: The relief of angina pectoris and the improvement of cardiac function in the two groups after one month of treatment
timeFrame: Baseline and 1 months.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital, Southern medical university
state: Guangdong
Study officials:
References: