Cardiovascular Ultrasound for the Rehabilitation of Patients With Coronary Heart Disease After PCI

NCT06640400 · tracked via the Priya Life Science China tracker

Sponsor

Qilu Hospital of Shandong University

Phase

Not applicable

Started

2024-10-25

Last updated

2024-10-15

Condition(s) studied

Coronary Heart Disease

Investigational drug(s) / intervention(s)

Cardiovascular ultrasound

Cardiovascular 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\&amp;amp;amp;#39;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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Qilu Hospital of Shandong University	Jinnan	Shandong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06640400 on ClinicalTrials.gov ↗ ← All trials in China