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Activo, sin reclutamientoNCT07094321Registro de ClinicalTrials.gov

Study on the Correlation Between Intraoperative Hypotension and Postoperative Myocardial Injury

Myocardial Injury After Noncardiac Surgery (MINS) · Hypotension During Surgery

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
12 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
10000 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The investigators are conducting an important study aimed at better understanding and predicting a potential complication after non-cardiac surgery: myocardial injury. This research is crucial for enhancing surgical safety and improving patient outcomes.

Simply put, postoperative myocardial injury (PMI) means that heart muscle cells are damaged after non-cardiac surgery. While it might not cause obvious chest pain like a heart attack, it can show up as abnormalities on an electrocardiogram (ECG) or in blood tests (like elevated troponin levels). This type of injury is a significant factor contributing to postoperative complications and even mortality.

During surgery, hypotension-or low blood pressure-is a common occurrence. The investigators know that maintaining adequate blood pressure is essential for the heart to receive a sufficient blood supply. If blood pressure drops too low, the heart's blood supply can be reduced, potentially leading to oxygen deprivation and damage to heart muscle cells.

While it's widely accepted that low blood pressure is linked to myocardial injury, precisely defining "low blood pressure" during surgery has been a persistent challenge.

  • Historically, the investigators have focused on the "absolute value" of blood pressure, such as a fixed mean arterial pressure (MAP) threshold (e.g., below 65 mmHg). Many studies have indeed shown that MAP below 65 mmHg, especially for extended periods, increases the risk of PMI.
  • However, recent research is starting to challenge this perspective. Some studies have found that even maintaining a relatively higher blood pressure during surgery (e.g., MAP above 75 mmHg) didn't significantly reduce the incidence of PMI. This suggests that simply looking at a fixed blood pressure number might not tell the whole story.

The investigators will be reviewing patient data from non-cardiac surgeries performed at China-Japan Friendship Hospital between 2020 and 2025. The investigators will meticulously analyze these patients' intraoperative blood pressure changes (considering both absolute values and the percentage change from their pre-operative baseline) and compare these findings with whether they developed myocardial injury after surgery.

Our study's goal is to determine which definition of low blood pressure (absolute value or percentage drop from baseline) is more closely related to postoperative myocardial injury.

The investigators will collect detailed patient information, including demographics, past medical history, pre- and post-operative test results, intraoperative vital signs, and intraoperative medications. All data will undergo rigorous statistical analysis to ensure the scientific validity and reliability of our findings.

The results of this study will help us more accurately identify patients at high risk for postoperative myocardial injury. If our hypothesis is confirmed, it means that during surgery, doctors, in addition to monitoring absolute blood pressure values, will pay closer attention to the degree of blood pressure drop relative to a patient's own normal baseline. This will help to:

  • Improve understanding of individual patient differences: Recognizing that what's "normal" for one patient might be too low for another.
  • Enable more precise adjustments in anesthesia and surgical management: Allowing for timely interventions to maintain optimal heart muscle perfusion, thereby reducing the incidence of postoperative myocardial injury.
  • Ultimately, enhance patient safety during surgery and improve their recovery and long-term outcomes.

An additional analysis examined whether blood pressure at hospital admission and its change before anesthesia helped identify patients at higher risk, and whether the relationship between blood pressure during surgery and heart muscle injury differed across these groups. The researchers also examined these associations separately using data from the INSPIRE database.

Leer la descripción completa

The original retrospective cohort study at China-Japan Friendship Hospital compared the associations of absolute intraoperative mean arterial pressure (MAP) and percentage decreases from preoperative baseline MAP with postoperative myocardial injury.

A subsequent exploratory secondary analysis examined the joint association of admission MAP and change in MAP from hospital admission to operating-room entry before induction (ΔMAP, calculated as operating-room entry MAP minus admission MAP) with postoperative myocardial injury. The analysis also assessed whether the association between intraoperative MAP exposure and postoperative myocardial injury varied across profiles defined by admission MAP and ΔMAP.

De-identified data from the INSPIRE database were analyzed separately to assess whether these associations were consistent in an external cohort.

¿Quién podría participar?

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Inclusion Criteria:

1. Patients who underwent elective non-cardiac, non-emergency surgery with general anesthesia at China-Japan Friendship Hospital between 2020 and 2025.
2. Surgical duration greater than 1 hour.
3. At least one valid cardiac troponin measurement within 72 hours after the end of surgery.
4. Patients with American Society of Anesthesiologists (ASA) physical status classification of I-III.

Exclusion Criteria:

1. Patients younger than 12 years old.
2. Patients undergoing organ transplant surgery.
3. Patients with more than 10 consecutive minutes of invalid or missing intraoperative vital signs data (For the hospital cohort only).
4. Patients with critical missing data that cannot be reasonably imputed (general data completeness issues).

Población del estudio

This study retrospectively includes adult patients (aged 12 years and older) who underwent elective, non-cardiac, non-emergency surgery under general anesthesia at China-Japan Friendship Hospital between January 2020 and December 2025. All included patients had a surgical duration exceeding 1 hour and an American Society of Anesthesiologists (ASA) physical status classification of I to III. At least one valid cardiac troponin measurement within 72 hours after the end of surgery.

The hospital cohort's exclusion criterion for more than 10 consecutive minutes of invalid or missing intraoperative vital-sign data was not applied to the INSPIRE cohort.

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
No informado
Enmascaramiento
No informado
MINS group

Patients who experienced postoperative cardiac dysfunction

Non-MINS group

Patients who did not experience postoperative cardiac dysfunction

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

occurrence of postoperative myocardial injury

Plazo: Within 72 hours after the end of surgery

PMI is defined as an elevation of cardiac troponin (e.g., high-sensitivity troponin I or T) levels above the 99th percentile upper reference limit (URL) of the local institutional laboratory within 72 hours after the end of surgery. This outcome will be assessed based on routine postoperative cardiac biomarker measurements performed as part of standard clinical care. PMI serves as a critical indicator for evaluating cardiac damage post-surgery and is closely associated with adverse patient outcomes and prognosis.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (1)

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1 centros

China-japan Friendship HospitalBeijing, Beijing Municipality, ChinaEstado desconocido

Equipo y fechas

Patrocinador principal
China-Japan Friendship Hospital
Inicio del estudio
1 ene 2025 Real
Finalización primaria
30 jul 2027 Estimado
Finalización del estudio
30 dic 2028 Estimado
Primera publicación
30 jul 2025 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Predicting Postoperative Myocardial Injury: A Retrospective Cohort Study Comparing Absolute Versus Relative Definitions of Intraoperative Hypotension

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026