Evidence map›Paper›PMID 37352324›Full record

Trial reportPloS one2023

A randomized, double-blind, placebo-controlled pilot trial of low-intensity pulsed ultrasound therapy for refractory angina pectoris.

Tomohiko Shindo, Kenta Ito, Tsuyoshi Ogata, Ryo Kurosawa, Kumiko Eguchi, Yuta Kagaya, Kenichiro Hanawa, Yuhi Hasebe, Kensuke Nishimiya, Takashi Shiroto and 13 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06640400 (A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06640400 nanot yet recruitingnot on this mapstarted 2024, after this paper: background citation

A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease

TypeinterventionalSponsorQilu Hospital of Shandong UniversityRan2024 to 2025Enrolled200ConditionsCoronary Heart DiseaseArmsCardiovascular ultrasound
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Tomohiko ShindoDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.ORCID 0000-0003-3420-9999
Kenta ItoDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Tsuyoshi OgataDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Ryo KurosawaDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Kumiko EguchiDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yuta KagayaDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Kenichiro HanawaDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yuhi HasebeDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Kensuke NishimiyaDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Takashi ShirotoDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Jun TakahashiDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yasuo OkumuraDepartment of Medicine, Nihon University Graduate School of Medicine, Tokyo, Japan.
Teruo NoguchiDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
Yukio OzakiDepartment of Cardiology, Fujita Health University School of Medicine, Toyoake, Japan.
Hiroyuki DaidaDepartment of Cardiology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Nobuhisa HagiwaraDepartment of Cardiology, Tokyo Women's Medical University Graduate School of Medicine, Tokyo, Japan.
Tohru MasuyamaCardiovascular Division, Department of Internal Medicine, Hyogo Medical University Graduate School of Medicine, Nishinomiya, Japan.
Taishiro ChikamoriDepartment of Cardiology, Tokyo Medical University, Tokyo, Japan.
Yoshihiro FukumotoKurume University School of Medicine, Kurume, Japan.
Kenichi TsujitaDivision of Cardiovascular Medicine, Department of Internal Medicine, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan.ORCID 0000-0002-4314-259X
Hiroshi KanaiDivision of Biomedical Measurements and Diagnostics, Graduate School of Biomedical Engineering, Tohoku University, Sendai, Japan.ORCID 0000-0002-6567-1687
Satoshi YasudaDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Hiroaki ShimokawaDepartment of Cardiovascular Medicine, International University of Health and Welfare, Narita, Japan.ORCID 0000-0001-7534-4826

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite the advances in the treatment of cardiovascular diseases, effective treatment remains to be established to improve the quality of life and prognosis of patients with chronic coronary syndromes. This study was aimed to evaluate the effectiveness and safety of the low-intensity pulsed ultrasound (LIPUS) therapy, which we have developed as a novel non-invasive angiogenic therapy through upregulation of endothelial nitric oxide synthase (eNOS). METHODS AND

findingsWe conducted a randomized, double-blind, placebo-controlled (RCT) pilot trial of the LIPUS therapy for patients with refractory angina pectoris. The patients who received optimal medical therapy without indication of PCI or CABG due to the lack of graftability or complexity of coronary lesions were enrolled. They were randomly divided into the LIPUS treatment group (N = 31) and the placebo group (N = 25) in a 1:1 fashion. The LIPUS therapy was performed in a transthoracic manner for 20 min for 3 sections each (mitral, papillary muscle, and apex levels) under the conditions that we identified; frequency 1.875 MHz, intensity 0.25 MPa, and 32 cycles. The primary endpoint was weekly use of nitroglycerin. Secondary endpoints included stress myocardial perfusion imaging and others. The average weekly nitroglycerin use (times/week) was decreased from 5.50 to 2.44 in the LIPUS group and from 5.94 to 2.83 in the placebo group. The changes in the average weekly nitroglycerin use were comparable; -3.06 (95% CI: -4.481 to -1.648) in the LIPUS group (P<0.01) and -3.10 (95% CI: -4.848 to -1.356) in the placebo group (P<0.01). No adverse effects were noted.

conclusionsIn the present study, the LIPUS therapy did not further ameliorate chest pain as compared with optimal medications alone in patients with refractory angina pectoris. The present findings need to be confirmed in another trial with a large number of patients. (Registration ID: UMIN000012369).

Indexed as

NitroglycerinPercutaneous Coronary InterventionAngina PectorisDouble-Blind MethodHumansPilot ProjectsQuality of LifeTreatment OutcomeUltrasonic WavesNitroglycerin

Identifiers

PMID37352324
PMCPMC10289346

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.