Angina PectorisNCT06480097
Bidirectional Cohort Study on Improvement of Quality of Life in Patients After Coronary Intervention With Kuanxiong Aerosol
An observational study of Angina Pectoris and Kuanzhong Aerosol, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angina Pectoris, Kuanzhong Aerosol, Quality of Life
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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\'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
Who cannot join
- 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 \>180mmHg and/or diastolic blood pressure \>110mmHg
- severe hepatic and renal insufficiency (ALT, AST or TBIL\>1.5 times the upper limit of normal reference value, Cr \>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
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, 510515
About this study
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.
- Conditions
- Angina Pectoris, Kuanzhong Aerosol, Quality of Life, Cardiac Function
- Keywords
- quality of life, Kuanxiong Aerosol, angina pectoris, Cardiac function
- Medical subject headings
- Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 months.
Secondary outcomes (1)
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.
Measured: Baseline and 1 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jan 2019
- Primary completion28 Jul 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480097
- Sponsor's protocol ID
- NFEC-2023-415
- Status last verified
- Aug 2025
- First submitted
- 4 Jun 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bidirectional Cohort Study on Improvement of Quality of Life in Patients After Coronary Intervention With Kuanxiong Aerosol
- ClinicalTrials.gov ID
- NCT06480097
- Acronym / sponsor ID
- NFEC-2023-415
- Conditions
- Angina Pectoris, Kuanzhong Aerosol, Quality of Life, Cardiac Function
- Keywords
- quality of life, Kuanxiong Aerosol, angina pectoris, Cardiac function
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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\'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
Key exclusion criteria (8 listed)
- 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 \>180mmHg and/or diastolic blood pressure \>110mmHg
- severe hepatic and renal insufficiency (ALT, AST or TBIL\>1.5 times the upper limit of normal reference value, Cr \>1.5 times the upper limit of normal reference value)
- Malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The improvement of quality of life in two groups after one month of treatment
Time frame: Baseline and 1 months.
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.
1 secondary outcome
The relief of angina pectoris and the improvement of cardiac function in the two groups after one month of treatment
Time frame: Baseline and 1 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris and Kuanzhong Aerosol, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of quality of life in two groups after one month of treatment (time frame: Baseline and 1 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.