NCT07772570

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
245mo left

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
May 2012Dec 2046

Study Start

First participant enrolled

May 1, 2012

Completed
14.3 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2046

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2046

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

34.4 years

First QC Date

August 14, 2026

Last Update Submit

August 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    Composite of cardiac mortality, heart failure, recurrent myocardial infarction, target vessel/lesion revascularization, life threatening arrhythmia

    20 years

Study Arms (4)

Acute Coronary Syndrome

Patients presenting with Acute Coronary syndrome (ST-segment elevation or non-ST-Segment Elevation

Diagnostic Test: blood samplingDiagnostic Test: Intracoronary ImagingDiagnostic Test: Cardiovascular Magnetic Resonance ImagingDiagnostic Test: Cardiac Computerised TomographyDiagnostic Test: Invasive Coronary Physiology

Stable ischemic heart disease

Patients presenting with suspicion of stable ischemic heart disease

Diagnostic Test: blood samplingDiagnostic Test: Intracoronary ImagingDiagnostic Test: Cardiovascular Magnetic Resonance ImagingDiagnostic Test: Cardiac Computerised TomographyDiagnostic Test: Invasive Coronary Physiology

Myocardial Injury

Patients presenting with objective evidence of myocardial injury

Diagnostic Test: blood samplingDiagnostic Test: Intracoronary ImagingDiagnostic Test: Cardiovascular Magnetic Resonance ImagingDiagnostic Test: Cardiac Computerised TomographyDiagnostic Test: Invasive Coronary Physiology

Healthy Controls

Healthy controls

Diagnostic Test: blood samplingDiagnostic Test: Cardiovascular Magnetic Resonance Imaging

Interventions

blood samplingDIAGNOSTIC_TEST

Blood sampling across different periprocedural and follow-up timepoints.

Acute Coronary SyndromeHealthy ControlsMyocardial InjuryStable ischemic heart disease
Intracoronary ImagingDIAGNOSTIC_TEST

Intracoronary Imaging with approved devices

Acute Coronary SyndromeMyocardial InjuryStable ischemic heart disease

Photon-counting CT

Acute Coronary SyndromeMyocardial InjuryStable ischemic heart disease

Angiography derived, Bolus Thermodilution, Continuous Thermodilution, Doppler Flow

Acute Coronary SyndromeMyocardial InjuryStable ischemic heart disease

Cardiovascular Magnetic Resonance Imaging (Multiparametric Phenotyping)

Acute Coronary SyndromeHealthy ControlsMyocardial InjuryStable ischemic heart disease

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients in whom safety or clinical concerns preclude participation.
  • Anaemia (Hb \<9).
  • Pregnant or breast feeding females.
  • 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)
  • patients with a known allergy to iodinated contrast media
  • eGFR\< 30 ml/min (stage 3-5 renal disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Heart Centre, John Radcliffe Hospital

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Keith M Channon

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 19, 2026

Study Start

May 1, 2012

Primary Completion (Estimated)

September 1, 2046

Study Completion (Estimated)

December 1, 2046

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Data may be shared upon reasonable request

Locations