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

Overview

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

• Device 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,

Primary outcome measures

• high-sensitivity C-reactive protein (hs-CRP) in serum [Time frame: Day 11 after PCI]
• Interleukin-6 (IL-6) levels [Time frame: Day 11 after PCI]

Secondary outcome measures (12)

• creatine kinase isoenzymes [Time frame: From enrollment to the end of treatment at 3rd month]
• cardiac troponin I [Time frame: From enrollment to the end of treatment at 3rd month]
• myeloperoxidase [Time frame: From enrollment to the end of treatment at 3rd month]
• total cholesterol [Time frame: From enrollment to the end of treatment at 3rd month]
• triglyceride [Time frame: From enrollment to the end of treatment at 3rd month]
• low-density lipoprotein cholesterol [Time frame: From enrollment to the end of treatment at 3rd month]
• high-density lipoprotein cholesterol [Time frame: From enrollment to the end of treatment at 3rd month]
• apolipoprotein A [Time frame: From enrollment to the end of treatment at 3rd month]
• apolipoprotein B [Time frame: From enrollment to the end of treatment at 3rd month]
• lipoprotein (a) [Time frame: From enrollment to the end of treatment at 3rd month]
• oxidized low-density lipoprotein [Time frame: From enrollment to the end of treatment at 3rd month]
• endothelial nitric oxide synthase [Time frame: From enrollment to the end of treatment at 3rd month]

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

• Patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction.
• Occlusion of branch vessels during PCI.
• Patients with perioperative use of hormones or immunosuppressants
• Combined infection or other inflammatory diseases
• Postoperative fever
• Patients are allergic to contrast media or cardiovascular ultrasound acoustic head-related materials.
• Changes in lipid-lowering, antiplatelet, and antihypertensive drug regimens during treatment.
• Patients with a clear diagnosis of autoimmune disease
• Patients who have undergone other surgeries in the past 7 days or have a history of trauma.
• Patients infected with novel coronavirus in the past month.
• Previous PCI treatment
• Previous cardiovascular ultrasound treatment
• Diabetic patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Qilu Hospital of Shandong University — Jinnan

Publications

• Liang W, Liang B, Yan K, Zhang G, Zhuo J, Cai Y. Low-Intensity Pulsed Ultrasound: A Physical Stimulus with Immunomodulatory and Anti-inflammatory Potential. Ann Biomed Eng. 2024 Aug;52(8):1955-1981. doi: 10.1007/s10439-024-03523-y. Epub 2024 Apr 29. PMID 38683473
• Zhu H, He M, Wang YL, Zhang Y, Dong J, Chen BY, Li YL, Zhou LJ, Du LJ, Liu Y, Zhang WC, Ta D, Duan SZ. Low-intensity pulsed ultrasound alleviates doxorubicin-induced cardiotoxicity via inhibition of S100a8/a9-mediated cardiac recruitment of neutrophils. Bioeng Transl Med. 2023 Jul 7;8(6):e10570. doi: 10.1002/btm2.10570. eCollection 2023 Nov. PMID 38023700
• Watanabe T, Matsumoto Y, Nishimiya K, Shindo T, Amamizu H, Sugisawa J, Tsuchiya S, Sato K, Morosawa S, Ohyama K, Watanabe-Asaka T, Hayashi M, Kawai Y, Takahashi J, Yasuda S, Shimokawa H. Low-intensity pulsed ultrasound therapy suppresses coronary adventitial inflammatory changes and hyperconstricting responses after coronary stent implantation in pigs in vivo. PLoS One. 2021 Sep 13;16(9):e0257175. PMID 34516572
• Signori LU, Rubin Neto LJ, Jaenisch RB, Puntel GO, Nunes GS, Paulitsch FS, Hauck M, Silva AMVD. Effects of therapeutic ultrasound on the endothelial function of patients with type 2 diabetes mellitus. Braz J Med Biol Res. 2023 Jun 26;56:e12576. doi: 10.1590/1414-431X2023e12576. eCollection 2023. PMID 37377306
• de Avila Santana L, Alves JM, Andrade TA, Kajiwara JK, Garcia SB, Gomes FG, Frade MA. Clinical and immunohistopathological aspects of venous ulcers treatment by Low-Intensity Pulsed Ultrasound (LIPUS). Ultrasonics. 2013 Apr;53(4):870-9. doi: 10.1016/j.ultras.2012.12.009. Epub 2012 Dec 23. PMID 23294989
• Shindo T, Ito K, Ogata T, Kurosawa R, Eguchi K, Kagaya Y, Hanawa K, Hasebe Y, Nishimiya K, Shiroto T, Takahashi J, Okumura Y, Noguchi T, Ozaki Y, Daida H, Hagiwara N, Masuyama T, Chikamori T, Fukumoto Y, Tsujita K, Kanai H, Yasuda S, Shimokawa H. A randomized, double-blind, placebo-controlled pilot trial of low-intensity pulsed ultrasound therapy for refractory angina pectoris. PLoS One. 2023 Jun PMID 37352324
• Shindo T, Ito K, Ogata T, Hatanaka K, Kurosawa R, Eguchi K, Kagaya Y, Hanawa K, Aizawa K, Shiroto T, Kasukabe S, Miyata S, Taki H, Hasegawa H, Kanai H, Shimokawa H. Low-Intensity Pulsed Ultrasound Enhances Angiogenesis and Ameliorates Left Ventricular Dysfunction in a Mouse Model of Acute Myocardial Infarction. Arterioscler Thromb Vasc Biol. 2016 Jun;36(6):1220-9. doi: 10.1161/ATVBAHA.115.306477. PMID 27079882
• Li J, Zhang Q, Ren C, Wu X, Zhang Y, Bai X, Lin Y, Li M, Fu J, Kopylov P, Wang S, Yu T, Wang N, Xu C, Zhang Y, Yang B. Low-Intensity Pulsed Ultrasound Prevents the Oxidative Stress Induced Endothelial-Mesenchymal Transition in Human Aortic Endothelial Cells. Cell Physiol Biochem. 2018;45(4):1350-1365. doi: 10.1159/000487561. Epub 2018 Feb 15. PMID 29462805

Identifiers

NCT: NCT06640400 · KYLL-202308-006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗