A study protocol of the rehabilitative efficacy of cardiovascular ultrasound therapy after percutaneous coronary intervention in patients with coronary artery disease: A multicenter, parallel-group, randomized controlled study.

Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE

Original Publication: San Francisco, CA : Public Library of Science

Coronary Artery Disease*/rehabilitation ; Coronary Artery Disease*/surgery ; Coronary Artery Disease*/therapy ; Percutaneous Coronary Intervention*/rehabilitation ; Ultrasonic Therapy*/methods; C-Reactive Protein/metabolism ; Humans ; Male ; Female ; Middle Aged ; Prospective Studies ; Aged ; Treatment Outcome ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic

Background: Coronary artery disease (CAD) is a leading cause of mortality and disability, placing heavy burdens on healthcare systems. Although cardiovascular ultrasound therapy has demonstrated effectiveness and safety in improving refractory angina, relevant clinical studies are rare and clinical evidence is lacking.
Methods and Design: This is a prospective, parallel-group, randomized controlled trial. We enrolled 200 patients with coronary artery disease who had undergone percutaneous coronary intervention (PCI) and randomized them into two groups. The intervention group will be given usual-practice plus cardiovascular ultrasound therapy intervention and the control group will be given only usual-practice intervention. After 20 treatments with cardiovascular ultrasound therapy, high-sensitivity C-reactive protein in serum will be used as the primary outcome measures. The following will be used in determining secondary outcomes: indicators of serum myocardial injury, blood lipid levels, markers of endothelial function, inflammatory factors, hemodynamic indicators, echocardiography, ultrasound examination for carotid plaques, 6-minute walk test, short-term variability in heart rate, and mental health assessment. The researchers plan to test the outcome indicators at multiple time points. Statistical analyses will be performed using SPSS version 26 statistical software (IBM, Armonk, NY).
Discussion: This is the first clinical study of the rehabilitative efficacy of cardiovascular ultrasound therapy in the treatment of CAD after PCI. Clinical recovery currently depends mainly on modalities such as medication, exercise, and nutritional therapy; therefore, cardiovascular ultrasound therapy, as a new mode of therapy, might become a major advance in the treatment of CAD after PCI.
Trial Registration: ClinicalTrials.gov NCT06640400.
(Copyright: © 2025 He et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The authors have declared that no competing interests exist.

BMJ Open. 2022 Mar 25;12(3):e056943. (PMID: 35338064)
Cardiovasc Drugs Ther. 2022 Jun;36(3):413-424. (PMID: 35156147)
PLoS One. 2021 Sep 13;16(9):e0257175. (PMID: 34516572)
Ann Biomed Eng. 2024 Aug;52(8):1955-1981. (PMID: 38683473)
Clin Exp Pharmacol Physiol. 2021 Nov;48(11):1500-1514. (PMID: 34343366)
Biochem Med (Zagreb). 2021 Feb 15;31(1):010502. (PMID: 33380887)
IEEE Trans Biomed Eng. 2019 Oct;66(10):2704-2718. (PMID: 30596564)
Sci Rep. 2024 Jun 14;14(1):13704. (PMID: 38871832)
Cardiovasc Res. 2021 Apr 23;117(5):1325-1338. (PMID: 32683442)
Bioeng Transl Med. 2023 Jul 07;8(6):e10570. (PMID: 38023700)
Braz J Med Biol Res. 2023 Jun 26;56:e12576. (PMID: 37377306)
PLoS One. 2023 Jun 23;18(6):e0287714. (PMID: 37352324)
Circulation. 2012 Dec 18;126(25):e354-471. (PMID: 23166211)
Heart. 2020 Sep;106(18):1380-1386. (PMID: 32522821)
Cardiovasc Interv Ther. 2024 Oct;39(4):335-375. (PMID: 39302533)
Autophagy. 2020 Jul;16(7):1262-1278. (PMID: 31500508)
Eur Heart J. 1996 Mar;17(3):354-81. (PMID: 8737210)
Arterioscler Thromb Vasc Biol. 2016 Jun;36(6):1220-9. (PMID: 27079882)
J Biomater Appl. 2022 Sep;37(3):402-414. (PMID: 35574901)
Ultrasonics. 2013 Apr;53(4):870-9. (PMID: 23294989)
Clin Transl Med. 2024 Jul;14(7):e1749. (PMID: 38951127)
Curr Cardiol Rep. 2020 Jan 21;22(2):7. (PMID: 31965355)
Front Endocrinol (Lausanne). 2023 Nov 28;14:1286900. (PMID: 38089611)
Cell Physiol Biochem. 2018;45(4):1350-1365. (PMID: 29462805)
PLoS One. 2014 Aug 11;9(8):e104863. (PMID: 25111309)
Transl Androl Urol. 2016 Apr;5(2):255-66. (PMID: 27141455)
Eur J Med Res. 2023 Sep 1;28(1):311. (PMID: 37658418)
J Zhejiang Univ Sci B. 2021 Oct 15;22(10):818-838. (PMID: 34636186)
JAMA Cardiol. 2023 Feb 1;8(2):192-201. (PMID: 36515941)
Front Immunol. 2023 Sep 07;14:1248056. (PMID: 37744362)
J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. (PMID: 33309175)

ClinicalTrials.gov NCT06640400

9007-41-4 (C-Reactive Protein)

Date Created: 20251016 Date Completed: 20251016 Latest Revision: 20251125

20260130

PMC12530608

10.1371/journal.pone.0327557

41100539