Evidence map›Paper›PMID 27856475›Full record

Observational studyBMJ open2016

Assessment of CardiOvascular Remodelling following Endovascular aortic repair through imaging and computation: the CORE prospective observational cohort study protocol.

Foeke J H Nauta, Arnoud V Kamman, El-Sayed H Ibrahim, Prachi P Agarwal, Bo Yang, Karen Kim, David M Williams, Joost A van Herwaarden, Frans L Moll, Kim A Eagle and 3 more

Registry-linked trialOpen access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02735720 (The CardiOvascular Remodeling Following Endovascular Aortic Repair), 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
2.3field-weighted citation impact, top 11% 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.

NCT02735720 terminatednot on this mapstarted 2017, after this paper: background citation

The CardiOvascular Remodeling Following Endovascular Aortic Repair (CORE) Study

Typeobservational_patient_registrySponsorUniversity of MichiganRan2017 to 2020Enrolled19ConditionsThoracic Aortic AneurysmArmsTEVAR, Non-TEVAR medical treatment
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 14 citations in OpenAlex.

  1. Cardiac remodelling following thoracic endovascular aortic repair for descending aortic aneurysms.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2019
    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

13 authors at 5 institutions in 3 countries.

Foeke J H NautaCardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan, USA.
Arnoud V KammanCardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan, USA.
El-Sayed H IbrahimDepartment of Radiology, University of Michigan, Ann Arbor, Michigan, USA.
Prachi P AgarwalDepartment of Radiology, University of Michigan, Ann Arbor, Michigan, USA.
Bo YangDepartment of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA.
Karen KimDepartment of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA.
David M WilliamsDepartment of Radiology, University of Michigan, Ann Arbor, Michigan, USA.
Joost A van HerwaardenDepartment of Vascular Surgery, University of Utrecht, Utrecht, Midden-Nederland, The Netherlands.
Frans L MollDepartment of Vascular Surgery, University of Utrecht, Utrecht, Midden-Nederland, The Netherlands.
Kim A EagleCardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan, USA.
Santi TrimarchiDepartment of Vascular Surgery, Thoracic Aortic Research Center, Policlinico San Donato IRCCS, University of Milan, Milan, Italy.
Himanshu J PatelDepartment of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA.
C Alberto FigueroaDepartments of Biomedical Engineering and Surgery, University of Michigan, Ann Arbor, Michigan, USA.
University of Michigan–Ann Arbor · USIRCCS Policlinico San Donato · ITUtrecht University · NLMichigan Medicine · USUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThoracic aortic stent grafts are orders of magnitude stiffer than the native aorta. These devices have been associated with acute hypertension, elevated pulse pressure, cardiac remodelling and reduced coronary perfusion. However, a systematic assessment of such cardiovascular effects of thoracic endovascular aortic repair (TEVAR) is missing. The CardiOvascular Remodelling following Endovascular aortic repair (CORE) study aims to (1) quantify cardiovascular remodelling following TEVAR and compare echocardiography against MRI, the reference method; (2) validate computational modelling of cardiovascular haemodynamics following TEVAR using clinical measurements, and virtually assess the impact of more compliant stent grafts on cardiovascular haemodynamics; and (3) investigate diagnostic accuracy of ECG and serum biomarkers for cardiac remodelling compared to MRI. METHODS AND ANALYSIS: This is a prospective, nonrandomised, observational cohort study. We will use MRI, CT, echocardiography, intraluminal pressures, ECG, computational modelling and serum biomarkers to assess cardiovascular remodelling in two groups of patients with degenerative thoracic aneurysms or penetrating aortic ulcers: (1) patients managed with TEVAR and (2) control patients managed with medical therapy alone. Power analysis revealed a minimum total sample size of 20 patients (α=0.05, power=0.97) to observe significant left ventricular mass increase following TEVAR after 1 year. Consequently, we will include 12 patients in both groups. Advanced MRI sequences will be used to assess myocardial and aortic strain and distensibility, myocardial perfusion and aortic flow. ECG, echocardiography and serum biomarkers will be collected and compared against the imaging data. Computational models will be constructed from each patient imaging data, analysed and validated. All measurements will be collected at baseline (prior to TEVAR) and 1-year follow-up. The expected study period is 3 years. ETHICS AND DISSEMINATION: This study has been approved by the University of Michigan IRB. The results will be disseminated through scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT02735720.

Indexed as

Ventricular RemodelingAdolescentAdultAgedAged, 80 and overAortic Aneurysm, ThoracicAortic DissectionBiomarkersComputer SimulationEchocardiographyEndovascular ProceduresFemaleHumansMagnetic Resonance ImagingMaleMichiganBiomarkersVASCULAR SURGERY

Identifiers

PMID27856475
PMCPMC5128949
OpenAlexW2550111282

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.