CORonary Thrombus Modification to Prevent MIcrovascular Damage in Patients With ST-segment Elevation Myocardial Infarction (The CORMI Trial)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

The aim of this study is to evaluate the effects of coronary thrombus modification on preventing the microvascular damage associated with primary percutaneous coronary intervention (PCI), and to limit the associated myocardial damage assessed by myocardial salvage index after 3 months. Furthermore, the project will evaluate coronary microvascular damage assessed invasively using both continuous and bolus thermodilution before and after stent implantation. In addition, the project will evaluate the diagnostic ability and associations of pre-stenting invasive physiological measurement to cardiac magnetic resonance imaging measurements.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ST-elevation at the J-junction in a minimum of two contiguous ECG leads with a minimum of ≥ 0.1 mV in all leads, except for V2 and V3 (which required ≥ 0.2 for men ≥ 40 years old, ≥ 0.25 in men < 40 years old, or ≥ 0.15 mV for all women) or new left bundle branch

Admission to hospital within 12 hours of symptom debut

Angiographic signs of a culprit lesion planned to be treated with primary percutaneous coronary intervention

Disqualifiers

Age < 18 years or inability to provide informed consent

Life expectancy of < 12 months

Hemodynamically instability

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coronary thrombus modification

    Procedure/Surgery

    Inflation of a short balloon not larger than the vessel size for 30 seconds following deflation for 30 seconds repeated a total of 4 times. Thereafter, patients will undergo standard stent implantation as per operator decision.

  • Standard stent implantation

    Procedure/Surgery

    Predilation before stent implantation will follow normal clinical guidelines, and to the discretion of the operator. patients will undergo standard stent implantation as per operator decision.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Coronary thrombus modificationExperimental treatment 1 intervention
Group B: Standard stent implantationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Myocardial salvage index

Calculated as the ratio of undamaged myocardium at 3 months to the area-at-risk ((Area-at-risk - final infarct size)/Area-at-risk)

Time frame
3 months

Secondary outcomes

1

CMR metrics of myocardial damage

Infarct size measured on CMR. Both the individual values and the change will be assessed.

Time frame
within 7 days and after 3 months
2

Left ventricular volumes by CMR

Left ventricular volumes measured by CMR. Both the individual values and the change between will be assessed.

Time frame
within 7 days after index procedure and after 3 months
3

LVEF measured by CMR

Left ventricular ejection fraction measured by CMR. Both the individual values and the change between will be assessed.

Time frame
within 7 days of index procedure and after 3 months
4

MVO measured by CMR

Microvascular obstruction measured by CMR. Both the individual values and the change between will be assessed.

Time frame
within 7 days and after 3 months

Other outcomes

Sponsors and contacts

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