Coronary Heart Disease
Conditions
Keywords
cardiovascular ultrasound, PCI, rehabilitation, coronary heart disease
Brief summary
The goal of this clinical trial is to learn the efficacy of cardiovascular ultrasound therapy on the rehabilitation of patients with coronary heart disease after PCI. It will also learn about the safety of cardiovascular ultrasound. The main questions it aims to answer are: Whether cardiovascular ultrasound improves cardiac function and prognosis in patients with coronary artery disease after PCI? What medical problems will participants experience after using cardiovascular ultrasound therapy? Researchers will compare cardiovascular ultrasound to a placebo (sham stimulation) to see if cardiovascular ultrasound works to treat coronary artery disease after PCI. Participants will: Patients were treated with cardiovascular ultrasound or placebo from the 24th hour after PCI for 20 minutes twice a day for 10 days. Examination and detection of serum inflammatory markers, endothelial function indicators, cardiac function, and heart rate variability at multiple time points (baseline (24 hours post-PCI), days 5 and 10 post-intervention, and months 1 and 3. Their symptoms were recorded, and depression and anxiety were scored.
Detailed description
Background Coronary heart disease (CHD) is one of the leading causes of mortality and disability and places a financial burden on the healthcare system. Although cardiovascular ultrasound has shown its effectiveness and safety in improving refractory angina, relevant clinical studies are rare, and clinical evidence is severely lacking. Methods and design This is a prospective, parallel-group, randomized control trial. We will enroll 200 patients with coronary artery disease after PCI and randomize them into 2 groups. The intervention group was given usual practice combined with cardiovascular ultrasound intervention and the control group was given usual practice combined with empty stimulation intervention. We used hs-CRP and IL-6 levels in serum after 20 times treatments with LIPUS as the primary outcome measures. Serum myocardial injury indicators levels and blood lipids indicators levels, markers of endothelial function levels, inflammatory factor levels, hemodynamic Indicators, Echocardiogram, 6-minute walk test, Short-term Heart rate variability, and mental health assessment were secondary outcomes. The researchers tested the outcome indicators at baseline (24th hours after PCI), 5th and 10th days, and 1st and 3rd months after the intervention. Statistical analyses were performed using SPSS 26.0 statistical software. Discussion This study is the first clinical study of the rehabilitation efficacy of cardiovascular ultrasound in the treatment of coronary heart disease after PCI. Given that the current clinical recovery mainly depends on the body's self-limiting and conventional symptomatic treatment, Cardiovascular ultrasound, as a new therapy method, might be a major advance in the treatment of coronary heart disease after PCI.
Interventions
DEVICECardiovascular ultrasound
Participants in the intervention group will be treated with a medical LIPUS device (838C-M-L-I/II, Shenzhen, China) for 10 days in addition to conventional medical treatment. The ultrasound therapy instrument is equipped with a sound head comprising 5 transducer units, operating at an ultrasonic frequency of 0.84MHz with a sound intensity range of 1 W/cm2 -1.25 W/cm2. The therapeutic ultrasound sessions necessitate a controlled environmental temperature. Patients will assume the supine position, exposing the precordial region, with the five-pronged head positioned parallel to the heart's long axis, covering the entire precordial region including the right and left coronary arterial trunks and the aortic root. The ultrasound therapy device operates in a pulsed mode, with each treatment session lasting 20 minutes, comprising 2 daily sessions for a total of 20 treatments.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Age of enrollment at least 18 years 2. Patients with confirmed coronary artery disease requiring elective PCI 3. TIMI flow grade 2 or above after PCI 4. No intraoperative complications of PCI such as entrapment, reflux, or perforation of coronary artery. 5\. The skin in the anterior chest area is intact and not broken. 6. Cardiac enzymes and troponin I are within normal range before enrollment.
Exclusion criteria
1. Patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction. 2. Occlusion of branch vessels during PCI. 3. Patients with perioperative use of hormones or immunosuppressants 4. Combined infection or other inflammatory diseases 5. Postoperative fever 6. Patients are allergic to contrast media or cardiovascular ultrasound acoustic head-related materials. 7. Changes in lipid-lowering, antiplatelet, and antihypertensive drug regimens during treatment. 8. Patients with a clear diagnosis of autoimmune disease 9. Patients who have undergone other surgeries in the past 7 days or have a history of trauma. 10. Patients infected with novel coronavirus in the past month. 11. Previous PCI treatment 12. Previous cardiovascular ultrasound treatment 13. Diabetic patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| high-sensitivity C-reactive protein (hs-CRP) in serum | Day 11 after PCI | High-sensitivity C-reactive protein (hs-CRP) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions. |
| Interleukin-6 (IL-6) levels | Day 11 after PCI | high-sensitivity C-reactive protein (hs-CRP) and Interleukin-6 (IL-6) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| myeloperoxidase | From enrollment to the end of treatment at 3rd month | Serum myeloperoxidase levels in fasting were collected and measured. |
| total cholesterol | From enrollment to the end of treatment at 3rd month | Serum total cholesterol levels in fasting were collected and measured |
| triglyceride | From enrollment to the end of treatment at 3rd month | Serum triglyceride levels in fasting were collected and measured. |
| low-density lipoprotein cholesterol | From enrollment to the end of treatment at 3rd month | Serum low-density lipoprotein cholesterol levels in fasting were collected and measured. |
| high-density lipoprotein cholesterol | From enrollment to the end of treatment at 3rd month | Serum high-density lipoprotein cholesterol levels in fasting were collected and measured. |
| apolipoprotein A | From enrollment to the end of treatment at 3rd month | Serum apolipoprotein A levels in fasting were collected and measured. |
| apolipoprotein B | From enrollment to the end of treatment at 3rd month | Serum apolipoprotein B levels in fasting were collected and measured. |
| lipoprotein (a) | From enrollment to the end of treatment at 3rd month | Serum lipoprotein (a) levels in fasting were collected and measured. |
| oxidized low-density lipoprotein | From enrollment to the end of treatment at 3rd month | Serum-oxidized low-density lipoprotein levels in fasting were collected and measured. |
| endothelial nitric oxide synthase | From enrollment to the end of treatment at 3rd month | Serum endothelial nitric oxide synthase levels in fasting were collected and measured. |
| endothelin-1 | From enrollment to the end of treatment at 3rd month | Serum endothelin-1 levels in fasting were collected and measured. |
| vascular endothelial growth factor | From enrollment to the end of treatment at 3rd month | Serum vascular endothelial growth factor levels in fasting were collected and measured. |
| procalcitonin | From enrollment to the end of treatment at 3rd month | Serum procalcitonin levels in fasting were collected and measured. |
| Systemic Vascular Resistance | From enrollment to the end of treatment at 3rd month | Stroke Systemic Vascular Resistance Index was collected and measured. |
| Mean Arterial Pressure | From enrollment to the end of treatment at 3rd month | Mean Arterial Pressure was collected and measured. |
| Stroke Volume Index | From enrollment to the end of treatment at 3rd month | Stroke Volume Index was collected and measured. |
| Stroke Volume | From enrollment to the end of treatment at 3rd month | Stroke Volume levels was collected and measured. |
| creatine kinase isoenzymes | From enrollment to the end of treatment at 3rd month | Serum creatine kinase isoenzyme levels in fasting were collected and measured |
| Cardiac Index | From enrollment to the end of treatment at 3rd month | The Cardiac Index was collected and measured. |
| Left Ventricular Stroke Work Index | From enrollment to the end of treatment at 3rd month | The left Ventricular Stroke Work Index was collected and measured. |
| Systemic Vascular Resistance Index | From enrollment to the end of treatment at 3rd month | The systemic Vascular Resistance Index was collected and measured. |
| Ejection Phase Contraction Index | From enrollment to the end of treatment at 3rd month | Ejection Phase Contraction Index was collected and measured. |
| Inotropic State Index | From enrollment to the end of treatment at 3rd month | Inotropic State Index was collected and measured. |
| Vascular Resistance | From enrollment to the end of treatment at 3rd month | Vascular Resistance was collected and measured. |
| Mean Heart Rate | From enrollment to the end of treatment at 3rd month | Mean Heart Rate was collected and measured. |
| left ventricular ejection fraction | From enrollment to the end of treatment at 3rd month | left ventricular ejection fraction was collected and measured |
| Wall thickening fraction | From enrollment to the end of treatment at 3rd month | Wall thickening fraction was collected and measured. |
| E/E' | From enrollment to the end of treatment at 3rd month | E/E' was collected and measured. |
| 6-minute walk test | From enrollment to the end of treatment at 3rd month | A 6-minute walk test was collected and measured. |
| Patient Health Questionnaire-9 | From enrollment to the end of treatment at 3rd month | Patient Health Questionnaire-9 was scored and collected. The Patient Health Questionnaire-9 (PHQ-9) serves as a critical instrument for the screening, diagnosis, and assessment of depression, enabling the measurement of its severity. |
| 7-item Generalized Anxiety Disorder Scale | From enrollment to the end of treatment at 3rd month | A 7-item Generalized Anxiety Disorder Scale (GAD-7) was scored and collected. GAD-7 acts as an essential tool for evaluating generalized anxiety disorder |
| The Pittsburgh Sleep Quality Index (PSQI) | From enrollment to the end of treatment at 3rd month | The Pittsburgh Sleep Quality Index (PSQI)was scored and collected. the Pittsburgh Sleep Quality Index (PSQI) stands as a widely recognized assessment tool for determining sleep quality. |
| Seattle Angina Questionnaire (SAQ) | From enrollment to the end of treatment at 3rd month | The Seattle Angina Questionnaire (SAQ) was scored and collected. SAQ functions as a self-administered assessment tool designed to evaluate specific functional status and quality of life among individuals with coronary artery disease. |
| Heart rate variability | From enrollment to the end of treatment at 3rd month | Heart rate variability was scored and collected. Heart rate variability (HRV) refers to the fluctuation in the timing of consecutive heartbeats or the variance in heart rate. It is determined by the duration between two successive R-R intervals, representing the slight deviation between each cardiac cycle. HRV assessment was conducted using the ZSY-1 Rhythm Variability Analyzer, with the patient in a supine position, and short-term (5-minute) HRV was measured during daytime hours (8:00-16:00) while at rest. |
| Cardiac Output | From enrollment to the end of treatment at 3rd month | Cardiac Output was collected and measured. |
| cardiac troponin I | From enrollment to the end of treatment at 3rd month | Serum cardiac troponin I levels in fasting were collected and measured |
Countries
China
Contacts
Primary ContactLin Shen, MD
Backup ContactChunwei He, MD
Outcome results
None listed