Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT03004703
Eligibility Criteria:
Inclusion Criteria:
Patients will be screened for eligibility upon admittance due to acute STEMI at either participating site. All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
* New ST elevation at the J-point in two contiguous leads (cut-points: 0.2mV in men and \>0.15 mV in women in leads V2-V3 and/or \>0.1 mV in other leads) in combination with symptoms consistent with acute MI.
* Presentation within 6 hours of chest pain.
* Indication for urgent coronary angiography with intent to reperfuse presumed occluded vessel.
* Age between 18 and 80 years.
* Informed consent obtained and documented according to ICH/GCP, and national/local regulations.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
* NSTEMI (non-ST segment elevation in ECG).
* Left bundle branch block in ECG
* History of previous MI
* Cardiogenic shock.
* Fibrinolytic therapy within 72 hours prior to admission.
* Cardiac arrest / ventricular fibrillation.
* History of severe renal failure with estimated glomerular filtration rate \< 30 ml/minutes.
* Known, current liver disease
* History of concurrent inflammatory, biliary obstructive or malignant disease
* A history of chronic or concurrent infectious disease, including a history of HIV, tuberculosis, or hepatitis B or C.
* Known, uncontrolled lower gastrointestinal (GI) disease such as diverticulitis, Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that could predispose to GI perforations
* Major surgery within 8 weeks prior or after baseline
* History of central nervous system demyelinating or seizure disorders
* History of primary or secondary immunodeficiency
* Treatment with immunosuppressants other than low dose corticosteroids (equivalent to 5 mg of prednisone or less) at the time of randomisation
* Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or to tocilizumab
* Other contraindications to study medication
* Pregnancy, possible pregnancy or breast-feeding - women of child-bearing potential or breastfeeding mothers cannot participate. A woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* Contraindications to CMR (pacemaker, CRT, ICD, certain ferromagnetic implants, severe claustrophobia, allergy to contrast medium).
* Any condition/circumstances believed to interfere with the ability to comply with protocol.
* Any reason why, in the opinion of the investigator, the patient should not participate.
* Failure to obtain written, informed consent by patient or next of kin, for instance in case of patient death after consent has been provided in oral.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03004703
Study Brief:
Protocol Section:
NCT03004703