Evidence map›Paper›PMID 36056444›Full record

ArticleTrials2022

Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR).

Gert Klug, Sebastian Reinstadler, Felix Troger, Magdalena Holzknecht, Martin Reindl, Christina Tiller, Ivan Lechner, Priscilla Fink, Mathias Pamminger, Christian Kremser and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
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 NCT03831087 (Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement), 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.

NCT03831087 nacompletednot on this map

Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Multicenter Trial

TypeinterventionalSponsorMedical University InnsbruckRan2017 to 2023Enrolled267ConditionsAortic StenosisArmsTAVR-CMR, TAVR-CT
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  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

14 authors at 1 institution in 1 country.

Gert KlugUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria. gert.klug@tirol-kliniken.at.ORCID http://orcid.org/0000-0002-4737-0979
Sebastian ReinstadlerUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Felix TrogerUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Magdalena HolzknechtUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Martin ReindlUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Christina TillerUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Ivan LechnerUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Priscilla FinkUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Mathias PammingerUniversity Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.
Christian KremserUniversity Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.
Hanno UlmerDepartment for Medical Statistics, Informatics and Health Economy, Medical University of Innsbruck, Innsbruck, Austria.
Axel BauerUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Bernhard MetzlerUniversity Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Agnes MayrUniversity Clinic of Radiology, Medical University of Innsbruck, Innsbruck, Austria.
Innsbruck Medical University · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe standard procedure for the planning of transcatheter aortic valve replacement (TAVR) is the combination of echocardiography, coronary angiography, and cardiovascular computed tomography (TAVR-CT) for the exact determination of the aortic valve dimensions, valve size, and implantation route. However, up to 80% of the patients undergoing TAVR suffer from chronic renal insufficiency. Alternatives to reduce the need for iodinated contrast agents are desirable. Cardiac magnetic resonance (CMR) imaging recently has emerged as such an alternative. Therefore, we aim to investigate, for the first time, the non-inferiority of TAVR-CMR to TAVR-CT regarding efficacy and safety end-points.

methodsThis is a prospective, randomized, open-label trial. It is planned to include 250 patients with symptomatic severe aortic stenosis scheduled for TAVR based on a local heart-team decision. Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR protocol or to receive a standard TAVR-CT protocol within 2 weeks after inclusion. Follow-up will be performed at hospital discharge after TAVR and after 1 and 2 years. The primary efficacy outcome is device implantation success at discharge. The secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 1 and 2 years, as well as a comparison of imaging procedure related variables. Endpoint definitions are based on the updated 2012 VARC-2 consensus document. DISCUSSION: TAVR-CMR might be an alternative to TAVR-CT for planning a TAVR procedure. If proven to be effective and safe, a broader application of TAVR-CMR might reduce the incidence of acute kidney injury after TAVR and thus improve outcomes.

trial registrationThe trial is registered at ClinicalTrials.gov (NCT03831087). The results will be disseminated at scientific meetings and publication in peer-reviewed journals.

Indexed as

Aortic Valve StenosisHeart Valve Prosthesis ImplantationTranscatheter Aortic Valve ReplacementAortic ValveEquivalence Trials as TopicHumansMagnetic Resonance ImagingProspective StudiesRandomized Controlled Trials as TopicRisk FactorsTomography, X-Ray ComputedTreatment OutcomeCardiac magnetic resonanceComputed tomographyKidney injuryTranscatheter aortic valve replacement

Identifiers

PMID36056444
PMCPMC9438296
OpenAlexW4294190612

What OpenQuestion holds

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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.