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Multimodal Biomarkers in Coronary Artery Disease Pathogenesis: The Oxford Acute Myocardial Infarction Study (OXAMI Study) (OXAMI)

21 de agosto de 2026 actualizado por: University of Oxford

Coronary artery disease is one of the most common causes of illness and death. It develops when fatty deposits, known as plaques, build up in the arteries that supply blood to the heart. These plaques can gradually narrow the arteries and reduce blood flow, causing symptoms such as chest pain (angina). Sometimes a plaque can suddenly break open, causing a blood clot to form and block the artery. This can lead to a heart attack and permanent damage to the heart muscle.

Although much has been learned about coronary artery disease, important questions remain about why some plaques suddenly become unstable, how this affects blood flow through the smallest blood vessels of the heart, and why some patients develop more heart muscle damage than others.

The Oxford Acute Myocardial Infarction (OxAMI) research programme aims to improve our understanding of these processes. The investigators will study both the disease within the coronary arteries (the "upstream" problem) and its effects on the heart muscle (the "downstream" damage). By examining these together, the investigators hope to understand more clearly how changes in coronary plaques lead to heart injury and how this differs between patients.

Participants undergoing procedures to investigate or treat coronary artery disease provide an important opportunity to study these processes. During coronary angioplasty (also called percutaneous coronary intervention or PCI), a narrow or blocked artery is opened, usually using a small balloon and a stent. This procedure can disturb the underlying plaque in a similar way to the plaque disruption that occurs during a heart attack. Where appropriate, the investigators may therefore collect blood and material released from the plaque during these procedures. Blood may be collected from different locations in the circulation, allowing the investigators to study substances released by the plaque and heart muscle. Material that would otherwise be discarded during treatment may also be collected for laboratory analysis.

The investigators will use several established and newer techniques to examine the coronary arteries, the small blood vessels within the heart, and the heart muscle. These may include detailed imaging from inside the coronary arteries using intravascular ultrasound (IVUS) or optical coherence tomography (OCT). The investigators may also measure blood pressure and flow within the coronary arteries to assess how well the small blood vessels supplying the heart are working.

Non-invasive heart scans may include cardiovascular magnetic resonance (CMR/MRI), cardiac computed tomography (CT) and echocardiography (ultrasound). These techniques can provide detailed information about the structure and function of the heart, blood supply to the heart muscle, areas of injury or permanent scarring, and changes that occur following a heart attack. In particular, MRI may help distinguish heart muscle that has been permanently damaged from muscle that is injured but could potentially recover after blood flow is restored. This may be especially important for participants who arrive at hospital several hours after their heart attack began.

Other measurements may include electrocardiograms (ECGs), which record the electrical activity of the heart, and measurements of heart pressure, volume and function. Some participants may also have longer-term ECG monitoring.

Blood and tissue samples may be analysed using a range of laboratory techniques. These studies will investigate inflammation, blood clotting and other biological processes involved in coronary artery disease and heart attacks. Newer laboratory methods may allow us to measure large numbers of proteins and small molecules in the blood. Material collected from plaques may also be examined under a microscope to identify its cells and structural components.

With additional consent, blood samples may be stored for genetic research. This could help us understand whether differences in people's genes influence their risk of coronary artery disease, their response to a heart attack, or the amount of heart damage that occurs.

By combining information about coronary plaques, blood flow through the heart's circulation, heart muscle injury, imaging, blood and tissue markers, and genetic factors, the OxAMI study aims to build a detailed picture of coronary artery disease and heart attacks. The programme will establish a carefully characterised group of research participants who may contribute to future OxAMI studies conducted under separate research protocols.

Ultimately, this research aims to identify better ways to predict, diagnose and understand coronary artery disease and heart attacks, and to identify new approaches that could improve treatment and outcomes for future patients.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

2000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Oxford, Reino Unido
        • Reclutamiento
        • Oxford Heart Centre, John Radcliffe Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Patients presenting with evidence of myocardial injury (e.g. elevation of troponin or other cardiac biomarkers, ECG changes, wall motion abnormalities on cardiac imaging) AND/OR referred for coronary angiography with view to proceed to PCI as indicated in either non-emergency or emergency settings.

Descripción

Inclusion Criteria:

  • Evidence of myocardial injury (e.g. elevation of troponin or other cardiac biomarkers, ECG changes, wall motion abnormalities on cardiac imaging) AND/OR referred for coronary angiography with view to proceed to PCI as indicated in either non-emergency or emergency settings.

Exclusion Criteria:

  • Patients in whom safety or clinical concerns preclude participation.
  • Anaemia (Hb <9).
  • Pregnant or breast feeding females.

Additional exclusion criteria for patients undergoing MRI

  • claustrophobia which limits / prevents participants from remaining in MRI scanner.
  • patients who cannot lie flat on the scan table.
  • patients with metallic implants, pacemakers, implantable defibrillators etc, unless known to be MRI compatible.
  • patients with known allergy to medium of contrast (gadolinium)

Additional exclusion criteria for patients undergoing coronary CT angiography

  • patients with a known allergy to iodinated contrast media
  • eGFR< 30 ml/min (stage 3-5 renal disease)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Acute Coronary Syndrome
Patients presenting with Acute Coronary syndrome (ST-segment elevation or non-ST-Segment Elevation
Blood sampling across different periprocedural and follow-up timepoints.
Intracoronary Imaging with approved devices
Cardiovascular Magnetic Resonance Imaging (Multiparametric Phenotyping)
Photon-counting CT
Angiography derived, Bolus Thermodilution, Continuous Thermodilution, Doppler Flow
Stable ischemic heart disease
Patients presenting with suspicion of stable ischemic heart disease
Blood sampling across different periprocedural and follow-up timepoints.
Intracoronary Imaging with approved devices
Cardiovascular Magnetic Resonance Imaging (Multiparametric Phenotyping)
Photon-counting CT
Angiography derived, Bolus Thermodilution, Continuous Thermodilution, Doppler Flow
Myocardial Injury
Patients presenting with objective evidence of myocardial injury
Blood sampling across different periprocedural and follow-up timepoints.
Intracoronary Imaging with approved devices
Cardiovascular Magnetic Resonance Imaging (Multiparametric Phenotyping)
Photon-counting CT
Angiography derived, Bolus Thermodilution, Continuous Thermodilution, Doppler Flow
Healthy Controls
Healthy controls
Blood sampling across different periprocedural and follow-up timepoints.
Cardiovascular Magnetic Resonance Imaging (Multiparametric Phenotyping)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Major adverse cardiovascular events
Periodo de tiempo: 20 years
Composite of cardiac mortality, heart failure, recurrent myocardial infarction, target vessel/lesion revascularization, life threatening arrhythmia
20 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Keith M Channon, University of Oxford

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2012

Finalización primaria (Estimado)

1 de septiembre de 2046

Finalización del estudio (Estimado)

1 de diciembre de 2046

Fechas de registro del estudio

Enviado por primera vez

14 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de agosto de 2026

Publicado por primera vez (Actual)

19 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data may be shared upon reasonable request

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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