NCT07700524Toborzás még nem indult
Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG
Quantitative Assessment of Native Coronary Artery and Bypass Graft Blood Flow Using Intraoperative Ultrasound in Patients Undergoing Coronary Artery Bypass Grafting: A Single-Centre Prospective Feasibility and Safety Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 11.
Rövid összefoglaló (regiszter, angolul)
This single-centre, prospective observational feasibility and safety study will enrol 190 consecutive adults undergoing elective isolated coronary artery bypass grafting (CABG) at Nanjing Drum Tower Hospital. The study aims to evaluate the feasibility and safety of intraoperative ultrasound for the quantitative assessment of native coronary artery and bypass graft blood flow. Transit-time flow measurement will be performed as part of routine intraoperative graft assessment. Additional ultrasound measurements will be obtained from major native coronary arteries before and after revascularisation and from bypass grafts after restoration of blood flow. The ultrasound findings will be collected for research purposes and will not influence graft revision or other intraoperative clinical decisions. The co-primary outcomes are the participant-level technical success rate of the protocol-defined intraoperative ultrasound assessment and the incidence of adverse events related to the ultrasound device or measurement procedure. Secondary outcomes include agreement between ultrasound and transit-time flow measurements, changes in native coronary artery blood flow after revascularisation, measurement repeatability, and exploratory associations between intraoperative flow parameters and postoperative cardiac function and myocardial injury biomarkers. Participants will be followed for 30 ± 7 days after surgery.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 190 (tervezett)
- Első benyújtás
- 2026. júl. 7.
- Kezdés
- 2027. jan. 1.
- Elsődleges befejezés
- 2028. dec. 31.
- Fő szponzor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07700524
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 190
- 2027. jan. 1. és az elsődleges befejezés (2028. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Endotracheal intubation and invasive mechanical ventilation before surgery.
- Chronic inflammatory or autoimmune disease, or long-term treatment with systemic corticosteroids or non-steroidal anti-inflammatory drugs.
- Previous cardiac surgery requiring repeat median sternotomy.
- Planned concomitant major cardiac or aortic surgery, including valve surgery, congenital heart defect repair, or aortic surgery.
- Inability or unwillingness to complete follow-up at 30 ± 7 days after surgery.
Más betegség
- History of malignancy.
- End-stage renal disease requiring maintenance dialysis before hospital admission.
- Severe pulmonary disease considered to preclude tolerance of elective coronary artery bypass grafting or to confer an unacceptably high perioperative risk.
- Severe peripheral vascular disease or clinical evidence of limb malperfusion before surgery.
- History of gastrointestinal ulceration or chronic inflammatory gastrointestinal disease.
- Active infection or sepsis at screening.
- Severe uncontrolled arrhythmia requiring urgent treatment or expected to cause marked intraoperative hemodynamic instability.
Egyéb
- Urgent, emergency, or salvage coronary artery bypass grafting.
- Prolonged preoperative fasting, as defined in the study protocol, or inability to maintain adequate oral intake without enteral or parenteral nutritional support.
- Body weight below 50 kg.
- Preoperative hemodynamic instability requiring ongoing resuscitation or mechanical circulatory support, including intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device support.
- Impaired consciousness, clinically significant central nervous system dysfunction, or evidence of cerebral malperfusion after hospital admission.
- Inability to understand the study information or unwillingness or inability to provide written informed consent.
- Pregnancy or breastfeeding.
Kiket keres a vizsgálat
- Aged 18 years or older.
- Confirmed coronary artery disease and scheduled to undergo elective isolated coronary artery bypass grafting at Nanjing Drum Tower Hospital.
- Able and willing to provide written informed consent before any study-specific procedures are performed.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School | Nanjing | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.