Clinical trial NCT06640400: Cardiovascular Ultrasound for the Rehabilitation of Patients With Coronary Heart Disease After PCI
Official title: A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Keywords: cardiovascular ultrasound
PCI
rehabilitation
coronary heart disease
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: high-sensitivity C-reactive protein (hs-CRP) in serum
timeFrame: Day 11 after PCI
measure: Interleukin-6 (IL-6) levels
timeFrame: Day 11 after PCI
Secondary outcomes:
measure: creatine kinase isoenzymes
timeFrame: From enrollment to the end of treatment at 3rd month
measure: cardiac troponin I
timeFrame: From enrollment to the end of treatment at 3rd month
measure: myeloperoxidase
timeFrame: From enrollment to the end of treatment at 3rd month
measure: total cholesterol
timeFrame: From enrollment to the end of treatment at 3rd month
measure: triglyceride
timeFrame: From enrollment to the end of treatment at 3rd month
measure: low-density lipoprotein cholesterol
timeFrame: From enrollment to the end of treatment at 3rd month
measure: high-density lipoprotein cholesterol
timeFrame: From enrollment to the end of treatment at 3rd month
measure: apolipoprotein A
timeFrame: From enrollment to the end of treatment at 3rd month
measure: apolipoprotein B
timeFrame: From enrollment to the end of treatment at 3rd month
measure: lipoprotein (a)
timeFrame: From enrollment to the end of treatment at 3rd month
measure: oxidized low-density lipoprotein
timeFrame: From enrollment to the end of treatment at 3rd month
measure: endothelial nitric oxide synthase
timeFrame: From enrollment to the end of treatment at 3rd month
measure: endothelin-1
timeFrame: From enrollment to the end of treatment at 3rd month
measure: vascular endothelial growth factor
timeFrame: From enrollment to the end of treatment at 3rd month
measure: procalcitonin
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Systemic Vascular Resistance
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Mean Arterial Pressure
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Stroke Volume Index
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Stroke Volume
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Cardiac Output
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Cardiac Index
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Left Ventricular Stroke Work Index
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Systemic Vascular Resistance Index
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Ejection Phase Contraction Index
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Inotropic State Index
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Systemic Vascular Resistance
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Vascular Resistance
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Mean Heart Rate
timeFrame: From enrollment to the end of treatment at 3rd month
measure: left ventricular ejection fraction
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Wall thickening fraction
timeFrame: From enrollment to the end of treatment at 3rd month
measure: E/E&#39;
timeFrame: From enrollment to the end of treatment at 3rd month
measure: 6-minute walk test
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Patient Health Questionnaire-9
timeFrame: From enrollment to the end of treatment at 3rd month
measure: 7-item Generalized Anxiety Disorder Scale
timeFrame: From enrollment to the end of treatment at 3rd month
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Seattle Angina Questionnaire (SAQ)
timeFrame: From enrollment to the end of treatment at 3rd month
measure: Heart rate variability
timeFrame: From enrollment to the end of treatment at 3rd month
Other outcomes:
Locations:
city: Jinnan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Jie Peng, MD
role: STUDY_CHAIR
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