Trhombus Aspiration in Hyperglycemic ST-elevation myocardiAl InfarcTIon
Condition: Hyperglycemia
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Hyperglycemia; Infarction
Study type: Observational

Summary: 
      Background. Patients with ST-Elevation Myocardial Infarction (STEMI) and hyperglycemia on
      admission have high rates of mortality (1). The management of hyperglycemic patients during
      STEMI is unclear. We evaluate whether the thrombus aspiration (TA) before primary
      percutaneous coronary intervention (PCI) may improve STEMI outcomes in hyperglycemic patients
      (2).

      Research Design and Methods. Consecutive 990 hyperglycemic patients with first STEMI
      undergoing quantitative coronary angiography were studied. Patients were categorized in two
      groups, either treated by thrombus aspiration v/s patients treated without thrombus
      aspiration. After discharge from the hospital, all patients will be managed and followed
      quarterly for 12 months month after event, as outpatients, to perform clinical evaluation,
      routine analyses and cardiovascular evaluation. The cardiovascular endpoint collected in both
      cohorts will include cardiac mortality, all-cause mortality and hospitalization for coronary
      disease and heart failure.

      Conclusions. We will attend improved outcomes in hyperglycemic patients treated by the TA
      before PCI, as compared to hyperglycemic patients treated only by PCI.
    

Detailed description: 
      The data analyzed in this study will be obtained from hyperglycemic STEMI patients who
      underwent primary PCI at the Department of Cardiology of the Cardarelli Hospital in Naples
      Italy between June 1, 2016, and December 1, 2017. This will be a prospective study to compare
      two therapeutic strategies: PCI plus thrombus aspiration (TA) versus PCI alone in patients
      with STEMI and hyperglycemia. According to the recent statement by the American Heart
      Association, hyperglycemia will be defined as an admission plasma glucose level of >140
      mg/dl. Inclusion criteria will include: age of 18 years or greater, presentation to the
      cardiac catheterization laboratory for PCI in the setting of first STEMI, admission plasma
      glucose level of >140 mg/dl. All STEMI patients will be referred to the cardiac
      catheterization laboratory within 12 h of presentation. Patients with left ventricular
      ejection fraction less than 25%, with previous myocardial infarction or previous PCI or/and
      coronary by-pass grafting, or had received fibrinolytic therapy will be excluded from the
      study. The following patients will be referred for urgent invasive diagnostics with the
      intention of performing PCI: symptom duration of 12 hours or less and ST-segment elevation of
      0.1 mV or greater in at least 2 contiguous leads (≥0.2 mV in V1-V3) or presumed new-onset
      left bundle-branch block. The investigation will be conformed with the principles outlined in
      the Declaration of Helsinki for use of human tissue or subjects. The Institutional Review
      Board will approve the protocol.

      Outcomes The primary outcome of the THAITI study will be all-cause mortality, cardiovascular
      deaths, recurrent myocardial infarction, cardiogenic shock, and class IV heart failure within
      360 days. Other outcomes will include target vessel revascularisation, stent thrombosis,
      stroke, and transient ischaemic attack within 360 days.
    

Intervention name(s): percutaneous coronary intervention
Intervention type(s): Device
Intervention description(s): Percutaneous coronary intervention. Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion. A minimum of two syringes (40 mL) of aspirate will be recommended. The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter. The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus. PCI procedure will be done without thrombectomy as per the investigator. Direct stenting will not be mandated in either treatment group. Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy. The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We will analyze the consecutive patients presenting with acute myocardial infarction and ST
        segment elevation (STEMI) admitted to the Department of Cardiology of the Cardarelli
        Hospital in Naples, Italy. Inclusion criteria will include: age of 18 years or greater,
        presentation to the cardiac catheterization laboratory for PCI in the setting of first
        STEMI, admission plasma glucose level ( >140 mg/dl in hyperglycemic Group). All STEMI
        patients will be referred to the cardiac catheterization laboratory within 12 h of
        presentation. Patients with left ventricular ejection fraction less than 25%, with previous
        myocardial infarction or previous PCI or/and coronary by-pass grafting will be excluded.