Evidence map›Paper›PMID 36494706›Full record

ArticleTrials2022

Safety and efficacy of direct cardiac shockwave therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial-an update.

Felix Nägele, Leo Pölzl, Michael Graber, Jakob Hirsch, Agnes Mayr, Mathias Pamminger, Felix Troger, Markus Theurl, Michael Schreinlechner, Nikolay Sappler and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03859466 (Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 29% of its field
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.

NCT03859466 nacompletednot on this map

Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting

TypeinterventionalSponsorMedical University InnsbruckRan2018 to 2023Enrolled63ConditionsHeart Failure Patients, Cardiac IschemiaArmsShockwave Therapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Extracorporeal shockwave therapy in tissue repair and regeneration.Wiener medizinische Wochenschrift (1946) · 2026
    Review
  2. 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

16 authors at 1 institution in 1 country.

Felix NägeleDepartment of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Leo PölzlDepartment of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Michael GraberDepartment of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Jakob HirschDepartment of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Agnes MayrDepartment of Radiology, Medical University of Innsbruck, Innsbruck, Austria.
Mathias PammingerDepartment of Radiology, Medical University of Innsbruck, Innsbruck, Austria.
Felix TrogerDepartment of Radiology, Medical University of Innsbruck, Innsbruck, Austria.
Markus TheurlDepartment of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.
Michael SchreinlechnerDepartment of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.
Nikolay SapplerDepartment of Internal Medicine III, Medical University of Innsbruck, Innsbruck, Austria.
Christian DorfmüllerHeart Regeneration Technologies, Innsbruck, Austria.
Martina MitrovicHeart Regeneration Technologies, Innsbruck, Austria.
Hanno UlmerDepartment of Medical Statistics, Informatics and Health Economics, Innsbruck, Austria.
Michael GrimmDepartment of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Can Gollmann-TepeköylüDepartment of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Johannes HolfeldDepartment of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. johannes.holfeld@i-med.ac.at.ORCID http://orcid.org/0000-0001-6623-0595
Innsbruck Medical University · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCoronary artery disease (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in the progressive replacement of contractile myocardium with dysfunctional, fibrotic scar tissue. Post-infarctional remodelling is causal for the concomitant decline of left-ventricular function and the fatal syndrome of heart failure. Available neurohumoral treatment strategies aim at the improvement of symptoms. Despite extensive research, therapeutic options for myocardial regeneration, including (stem)-cell therapy, gene therapy, cellular reprogramming or tissue engineering, remain purely experimental. Thus, there is an urgent clinical need for novel treatment options for inducing myocardial regeneration and improving left-ventricular function in ischemic cardiomyopathy. Shockwave therapy (SWT) is a well-established regenerative tool that is effective for the treatment of chronic tendonitis, long-bone non-union and wound-healing disorders. In preclinical trials, SWT regenerated ischemic myocardium via the induction of angiogenesis and the reduction of fibrotic scar tissue, resulting in improved left-ventricular function.

methodsIn this prospective, randomized controlled, single-blind, monocentric study, 80 patients with reduced left-ventricular ejection fraction (LVEF≤ 40%) are subjected to coronary-artery bypass-graft surgery (CABG) surgery and randomized in a 1:1 ratio to receive additional cardiac SWT (intervention group; 40 patients) or CABG surgery with sham treatment (control group; 40 patients). This study aims to evaluate (1) the safety and (2) the efficacy of cardiac SWT as adjunctive treatment during CABG surgery for the regeneration of ischemic myocardium. The primary endpoints of the study represent (1) major cardiac events and (2) changes in left-ventricular function 12 months after treatment. Secondary endpoints include 6-min walk test distance, improvement of symptoms and assessment of quality of life. DISCUSSION: This study aims to investigate the safety and efficacy of cardiac SWT during CABG surgery for myocardial regeneration. The induction of angiogenesis, decrease of fibrotic scar tissue formation and, thus, improvement of left-ventricular function could lead to improved quality of life and prognosis for patients with ischemic heart failure. Thus, it could become the first clinically available treatment strategy for the regeneration of ischemic myocardium alleviating the socio-economic burden of heart failure.

trial registrationClinicalTrials.gov NCT03859466. Registered on 1 March 2019.

Indexed as

CardiomyopathiesCoronary Artery DiseaseHeart FailureHigh-Energy Shock WavesMyocardial IschemiaCicatrixCoronary Artery BypassHumansProspective StudiesQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodStroke VolumeTreatment OutcomeVentricular Function, LeftCABGClinical trialHeart failureIschemic heart diseaseShockwave

Identifiers

PMID36494706
PMCPMC9733047
OpenAlexW4311672528

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.