GENECARD - the Use of Genetic, Epigenetic, Metabolomic, Proteomic and Microbiotic Markers, Image and Voice Biomarker Analyses, and Pre- and Intraoperative Clinical Data - to Predict Early Complications After Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- New-onset atrial fibrillation (NOAF)
研究概览
简要总结
The goal of this observational cohort study is to prove whether genetic, epigenetic, transcriptomic, proteomic, metabolomic, imaging, voice, and clinical markers can improve prediction of early complications after cardiac surgery in adult patients.
The main questions it aims to answer are:
Which biological and clinical markers are associated with: new-onset atrial fibrillation (NOAF), acute kidney injury (AKI), postoperative delirium (POD), vasoplegia, postoperative bleeding and 30-day mortality? Can combining these markers improve early prediction of postoperative complications compared with current clinical risk scores?
Researchers will analyze a wide range of data collected before, during, and after cardiac surgery and compare patients who develop early complications with those who do not to identify risk factors and early biomarkers.
Participants will:
Provide biological samples (blood, urine, stool) before and after surgery for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, and laboratory testing.
Undergo standard preoperative and intraoperative imaging and clinical assessments.
Allow collection of clinical data related to postoperative outcomes (For some participants) have voice and video recordings performed to help identify early signs of postoperative delirium.
This study aims to improve early detection of postoperative complications and support development of personalized diagnostic and treatment strategies for patients undergoing cardiac surgery.
详细描述
Single-center, prospective, translational, observational cohort study designed to identify markers that predict early postoperative complications in adult patients undergoing elective cardiac surgery. The study will analyze genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, imaging, voice, and detailed clinical data collected before, during, and after surgery. Approximately 2,000-3,000 participants will be enrolled between 2026 and 2029.
Study Objectives
The main objective is to determine whether selected biological and clinical markers can predict early postoperative complications, including:
New-onset atrial fibrillation (NOAF), Acute kidney injury (AKI), Postoperative delirium (POD), Vasoplegia, Postoperative bleeding 30-day mortality.
The study will use current clinical definitions: NOAF per ESC guidelines, AKI per KDIGO criteria, and POD per DSM-V, as well as validated delirium scales such as CAM-ICU or DOSS. Postoperative bleeding will be defined as >1000 mL drainage in 24 hours or the need for surgical re-exploration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old)
- •Undergoing elective cardiac surgery
- •Able and willing to provide informed consent
排除标准
- •Age below 18 years
- •Lack of informed consent
- •Prior or planned solid organ transplantation
- •Prior or planned bone marrow transplantation
研究组 & 干预措施
Elective Cardiac Surgery Patients
Adult men and women (≥18 years) undergoing elective cardiac surgery who provide informed consent are enrolled. Patients with a history of, or planned, solid organ or bone marrow transplantation are excluded. All participants are followed prospectively during and after surgery to determine the occurrence of early postoperative complications, including new-onset atrial fibrillation, acute kidney injury, postoperative delirium, vasoplegia, and postoperative bleeding, as well as in-hospital and 30-day mortality, duration of mechanical ventilation, and ICU and hospital length of stay.
干预措施: Multi-Omics Data and Clinical Data Collection (Other)
结局指标
主要结局
New-onset atrial fibrillation (NOAF)
时间窗: From end of surgery until hospital discharge, up to 14 days.
Occurrence of new-onset atrial fibrillation after cardiac surgery, defined according to current ESC guidelines, using clinical data, ECG and centrally recorded rhythm data.
Acute kidney injury (AKI)
时间窗: From end of surgery until hospital discharge, up to 14 days.
Occurrence of acute kidney injury after cardiac surgery, defined according to KDIGO criteria, using serial laboratory measurements (including serum creatinine and other kidney biomarkers).Early postoperative period after cardiac surgery during index hospitalization.
Postoperative delirium (POD)
时间窗: From end of surgery until hospital discharge, up to 14 days.
Occurrence of postoperative delirium after cardiac surgery, defined according to DSM-V criteria and assessed with validated delirium scales (e.g., CAM-ICU or DOSS), clinical observation, and supporting data (including voice and image recordings in selected patients).
Vasoplegia
时间窗: Perioperative period and postoperative hospitalization, up to 14 days.
Occurrence of vasoplegia after cardiac surgery, identified from perioperative and postoperative hemodynamic and clinical data according to prespecified criteria in the protocol.
Postoperative bleeding
时间窗: Within 24 hours after surgery and during hospitalization for re-exploration, up to 14 days.
Occurrence of significant postoperative bleeding after cardiac surgery, defined as blood loss \>1000 mL in chest drains within 24 hours or the need for surgical re-exploration due to bleeding.
次要结局
- In-hospital mortality(From date of surgery until hospital discharge or death, up to 14 days.)
- 30-day mortality(30 days after surgery.)
- Duration of mechanical ventilation(From end of surgery until final extubation, up to 7 days.)
- ICU length of stay(From ICU admission after surgery until ICU discharge, up to 7 days.)
- Postoperative hospital length of stay(From date of surgery until hospital discharge, up to 14 days.)
研究者
Maciej M. Kowalik, MD, PhD, DSc
Principal Investigator
Medical University of Gdansk