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

NCT06640400 | Not Yet Recruiting

• 1 other identifier: KYLL-202308-006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

cardiovascular ultrasound; PCI; rehabilitation; coronary heart disease

Outcome Measures

Primary Outcomes (2)

• high-sensitivity C-reactive protein (hs-CRP) in serum

  High-sensitivity C-reactive protein (hs-CRP) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions.

  Day 11 after PCI

• Interleukin-6 (IL-6) levels

  high-sensitivity C-reactive protein (hs-CRP) and Interleukin-6 (IL-6) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions

  Day 11 after PCI

Secondary Outcomes (37)

• creatine kinase isoenzymes

  From enrollment to the end of treatment at 3rd month

• cardiac troponin I

  From enrollment to the end of treatment at 3rd month

• myeloperoxidase

  From enrollment to the end of treatment at 3rd month

• total cholesterol

  From enrollment to the end of treatment at 3rd month

• triglyceride

  From enrollment to the end of treatment at 3rd month

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group received cardiovascular ultrasound plus conventional drug therapy.

Device: Cardiovascular ultrasound

Control group

NO INTERVENTION

The control group received conventional drug treatment.

Interventions

Cardiovascular ultrasound DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinnan, Shandong, 250000, China

Location

Related Publications (22)

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  PMID: 38683473 RESULT

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  PMID: 38023700 RESULT

• 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. doi: 10.1371/journal.pone.0257175. eCollection 2021.

  PMID: 34516572 RESULT

• 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.

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  PMID: 29462805 RESULT

• Hu Y, Jia Y, Wang H, Cao Q, Yang Y, Zhou Y, Tan T, Huang X, Zhou Q. Low-intensity pulsed ultrasound promotes cell viability and inhibits apoptosis of H9C2 cardiomyocytes in 3D bioprinting scaffolds via PI3K-Akt and ERK1/2 pathways. J Biomater Appl. 2022 Sep;37(3):402-414. doi: 10.1177/08853282221102669. Epub 2022 May 15.

  PMID: 35574901 RESULT

• Sun P, Li Y, Yu W, Chen J, Wan P, Wang Z, Zhang M, Wang C, Fu S, Mang G, Choi S, Du Z, Tang C, Li S, Shi G, Tian J, Dai J, Leng X. Low-intensity pulsed ultrasound improves myocardial ischaemia-reperfusion injury via migrasome-mediated mitocytosis. Clin Transl Med. 2024 Jul;14(7):e1749. doi: 10.1002/ctm2.1749.

  PMID: 38951127 RESULT

• Weng L, Li L, Zhao K, Xu T, Mao Y, Shu H, Chen X, Chen J, Wu J, Guo X, Tu J, Zhang D, Sun W, Kong X. Non-Invasive Local Acoustic Therapy Ameliorates Diabetic Heart Fibrosis by Suppressing ACE-Mediated Oxidative Stress and Inflammation in Cardiac Fibroblasts. Cardiovasc Drugs Ther. 2022 Jun;36(3):413-424. doi: 10.1007/s10557-021-07297-6. Epub 2022 Feb 14.

  PMID: 35156147 RESULT

• Zhao K, Zhang J, Xu T, Yang C, Weng L, Wu T, Wu X, Miao J, Guo X, Tu J, Zhang D, Zhou B, Sun W, Kong X. Low-intensity pulsed ultrasound ameliorates angiotensin II-induced cardiac fibrosis by alleviating inflammation via a caveolin-1-dependent pathway. J Zhejiang Univ Sci B. 2021 Oct 15;22(10):818-838. doi: 10.1631/jzus.B2100130.

  PMID: 34636186 RESULT

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  PMID: 34343366 RESULT

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  PMID: 32683442 RESULT

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  PMID: 41100539 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jie Peng, MD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Lin Shen, MD

CONTACT

18560082257; slmm321@126.com

Chunwei He, MD

CONTACT

17361616499; hechw160814@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 25, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)