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Идёт набор NCT07662317

Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery

— Наблюдательное Valve Heart Disease Coronary Artery Disease Coronary Heart Disease Aortic Diseases

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: Cardiac surgey.
Кому может быть актуально
Состояния в реестре: Valve Heart Disease, Coronary Artery Disease, Coronary Heart Disease, Aortic Diseases. Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019. Establishing a comprehensive cardiac surgery database is crucial for exploring perioperative prognostic factors and improving clinical outcomes. This muti-center, prospective observational study aims to construct a prospective cohort database for perioperative cardiac surgery. We plan to enroll adult patients who undergo cardiac surgery with cardiopulmonary bypass at the Second Affiliated Hospital of Zhejiang University and other hospitals from May 1, 2026 to December 31, 2031. Multi-dimensional perioperative data, including laboratory tests, hemodynamics, intraoperative echocardiography, and perioperative medications, will be collected and integrated, along with epidemiological data, clinical diagnosis and treatment information, multimodal data, and follow-up outcomes. An interconnected big data sharing platform will also be built. This database will provide a valuable resource for multi-level researches such as perioperative risk assessment, individualized prevention, precise diagnosis and treatment, and therapeutic efficacy monitoring. It will also help optimize surgical and perioperative management, improve the quality of cardiac surgery, and provide evidence for the refinement of China's healthcare system, ultimately enhancing perioperative safety and rehabilitation efficiency of patients.

Подробное описание

1\. Establish a cohort of perioperative surgical patients across multiple medical centers, tracking them from enrollment through 1 year post-surgery, and build a database of data relevant to patient outcomes; 2. Investigate the impact of preoperative psychological and physical factors on short-term postoperative complications in surgical patients, develop predictive models, and conduct prospective validation; 3. Investigate the impact of preoperative psychological, physical, and social factors on long-term postoperative complications; 4. Investigate the incidence of acute and chronic postoperative pain, associated risk factors, and their impact on prognosis; 5. Investigate the optimal perioperative transfusion strategies for allogeneic blood products based on causal relationships, develop predictive models, and validate them.

Вмешательства

  • Процедура Cardiac surgey
    Cardiac surgey

Первичные конечные точки

  • Incidence of major adverse cardiac and cerebrovascular events (MACCE) [Срок оценки: 4, 12 weeks and 1years after surgery]
  • Incidence of Perioperative Transfusion of Allogeneic Blood Products [Срок оценки: 30 days after surgery]
  • Amount of Allogeneic Blood Products Transfused During the Perioperative Period [Срок оценки: 30 days after surgery]
Вторичные конечные точки (10)
  • Incidence of perioperative myocardial infarction [Срок оценки: 4, 12 weeks and 1years after surgery]
  • Incidence of New-onset stroke [Срок оценки: 4, 12 weeks and 1years after surgery]
  • Incidence of death [Срок оценки: 4, 12 weeks and 1years after surgery]
  • Incidence of acute kidney injury [Срок оценки: 7days after suegery]
  • Incidence of infectious complications [Срок оценки: 4, 12 weeks and 1years after surgery]
  • Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery [Срок оценки: 4 and 12 weeks after surgery]
  • Length of hospital stay [Срок оценки: Through patients discharge, an average of 7 days after surgery]
  • Hospitalization costs [Срок оценки: Through patients discharge, an average of 7 days after surgery]
  • Quality of life scores [Срок оценки: at 4, 12 weeks and 1 years after surgery]
  • Quality of life scores [Срок оценки: at 4, 12 weeks and 1 years after surgery]

Критерии участия

Критерии включения

  • Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031

Критерии исключения

  • Refusal to provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Ханчжоу

Идентификаторы

NCT: NCT07662317 · 2026-0345

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗