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Идёт набор NCT05547607

Clinical and Diagnostic Features of Endocarditis

Наблюдательное Endocarditis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: advanced cardiac imaging.
Кому может быть актуально
Состояния в реестре: Endocarditis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Observational Prospective Multicenter Study to Characterize the cLinical ANd DiagnoStiC feAtures of Endocarditis in the contemPorary Era

Обзор

The burden of endocarditis has changed in the last years due to an increase in percutaneous valve procedures offered to a more fragile, and old population. Therefore an update in epidemiology data is necessary. The Observational prospective multicenter study to characterize the cLinical ANd DiagnoStiC feAtures of endocarditis in the contemPorary Era, (ENDO-LANDSCAPE study) is an observational, multicenter and international study. The study has two arms: retrospective and prospective. The retrospective arm will involve collecting data from patients discharged with a diagnosis of endocarditis between 2016 and 2022. The data obtained in the retrospective arm of the study will be utilized in a power calculation to determine the sample size for the prospective arm of the study. In the prospective phase in every participating center, all patients referred for echocardiography to assess for endocarditis and those with established endocarditis independent of the screened request will be eligible. Patients will then be stratified according to the presence or abscence of endocarditis. Those with an established diagnosis of endocarditis will be prospectively followed for outcomes.

Подробное описание

STUDY DESIGN The study will be multicenter and international with two arms: retrospective and prospective.

The retrospective arm will involve collecting data from patients discharged with a diagnosis of endocarditis between 2016 and 2022. The data obtained in the retrospective arm of the study will be utilized in a power calculation to determine the sample size for the prospective arm of the study.

Retrospective arm: It will be enrolled all patients discharged with a diagnosis of endocarditis. Data collected will be about: 1) position, size and type of valve or prosthesis infected, 2) echocardiographic data (both on transthoracic or transesophageal approach) regarding presence, size and morphology of vegetations and any other signs consistent with endocarditis (e.g.abscess, fistula, pseudoaneurysms), severity of valve disease; 3) imaging technique used for diagnosis in addition to echocardiography (computed tomography, positron emission computed tomography, single photon emission computed tomography); 4) management of the case performed by the endocarditis team (including cardiologist, microbiologist, cardiac surgeon, radiologist); 5) Duke criteria verification; 6) management of the case (conservative vs invasive); 7) antibiotic therapy prescribed and timing; 8) follow-up at one year (death, cardiac surgery, re-infection).

All data collected will be made anonymous. Data regarding follow-up will be obtained through medical chart or by hospital computer reporting systems. For this reason, a signed informed consent is not necessary for this phase of the study. All data will be collected in electronic format (e-CRF) on REDCAP.

Prospective arm: This phase will involve several international centres for a timeframe of 12 months.

All consecutive patients referred for a echocardiography with a suspicion of bacterial endocarditis and those with a confirmed diagnosis of endocarditis independently by the request will potentially be eligible for the study. Only the patients with a confirmed or with high suspicion of endocarditis will be prospectively followed for one year. As in the retrospective arm, these patients will be prospectively follow-up, and the following information collected: 1) type, size and position of infected valve or prosthesis, 2) echocardiographic data (both on transthoracic or transesophageal approaches) regarding presence, size and morphology of vegetations or other evidence of endocarditis (e.g. abscess, fistula, pseudoaneurysms), severity of valve disease; 3) imaging technique used for diagnosis in addition to echocardiography (computed tomography, positron emission computed tomography, single photon emission computed tomography); 4) management of the case performed by the endocarditis team (including cardiologist, microbiologist, cardiac surgeon, radiologist); 5) Duke criteria verification; 6) management of the case (conservative or invasive); 7) antibiotic therapy prescribed and timing; 8) follow-up at one year (death, cardiac surgery, re-infection).

For patients with no evidence of endocarditis on their echocardiogram, data on the following will be collected: i) size, type and position of valve prosthesis; ii) uke criteria verification.

In both cases a CRF will be filled. All patients enrolled in the prospective arm will sign a informed written consent.

Вмешательства

  • Диагностический тест advanced cardiac imaging
    In all patients with high suspected or confirmed endocarditis at the echocardiography the following information will be collected: 1) endocarditis risk factors, 2) type, size and position of infected valve or prosthesis, 3) echocardiographic data; 4) imaging technique used for diagnosis in addition to echocardiography; 5) management of the case performed by the endocarditis team (including cardiologist, microbiologist, cardiac surgeon, radiologist); 6) Duke criteria verification; 7) management o

Первичные конечные точки

  • incidence of endocarditis [Срок оценки: 1 year]
Вторичные конечные точки (5)
  • Appropriateness of requests for echocardiography to exclude endocarditis [Срок оценки: day 1]
  • All-cause mortality of surgically treated endocarditis [Срок оценки: 1 year]
  • All-cause mortality of medically managed endocarditis [Срок оценки: 1 year]
  • Cerebrovascular accident [Срок оценки: 1 year]
  • Re-infection in invasively treated endocarditis [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients above the age of 18 years.
  • all consecutive patients referred for echocardiography (transthoracic or transesophageal approach) to exclude endocarditis.
  • patients with a diagnosis of endocarditis on echocardiography independently by the request for the exam.

Критерии исключения

  • patient's refusal.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • University Hospital of Ferrara — Cona

Публикации

  • Pavasini R, Sinning C, Campo G, Tan TC. ObsErvatioNal prospective multicenter stuDy tO characterize the cLinical ANd DiagnoStiC feAtures of endocarditis in the contemPorary Era (ENDO-LANDSCAPE study): rationale and design. J Cardiovasc Med (Hagerstown). 2023 Jun 1;24(6):354-360. doi: 10.2459/JCM.0000000000001469. Epub 2023 Apr 6. PMID 37021952

Идентификаторы

NCT: NCT05547607 · 548/2022/Oss/AOUFe

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗