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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02483494
Eligibility Criteria:
Inclusion Criteria:
* Typical history of ischemic chest pain or angina equivalent symptoms (e.g. acute onset dyspnea)\> 30 minutes
* Undergone PCI for index event
* NT-Pro-BNP ≥1000 ng/L
* Cinically diagnosed AMI at high risk of ventricular remodeling (STEMI or NSTEMI):
(Anterior or large inferior STEMI)
* ECG changes\>0.1mV ST segment elevation in two or more contiguous limb leads or precordial leads or
* Presence of pathological Q waves in two or more contiguous limb leads or precordial leads.
* Typical rise or fall of cardiac enzymes (cardiac troponin value exceeding the 99th percentile).
* Angiographic findings of proximal/mid LAD, proximal LCX or RCA occlusion for STEMI.
(Or NSTEMI with)
* Typical rise or fall of cardiac enzymes (cTn value exceeding the 99th percentile).
* Peak cTnI should be \>10ug/L, TnT-hs\>250 ng/L or CK-MB \>80 IU/L
* LVEF (echocardiography) ≤ 40% or Kilip class ≥2
Exclusion Criteria:
* Hypersensitivity to ticagrelor, aspirin or any excipients
* Active pathological bleeding
* History of intracranial haemorrhage
* Infection within 6 weeks preceding the primary angioplasty, inflammatory disorders, Hepatitis, HIV, autoimmune disease or on immunosuppressive therapy
* Women of childbearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period.
* History of non-ischaemic cardiomyopathy or malignancy
* History of significant valvular heart disease (moderate or severe MS, MR, AS, AR, TR)
* Planned CABG within the next 6 weeks
* Cardiogenic shock unable to be weaned off inotropes or IABP
* Asthma or any other contraindications to beta-blockers
* Arrhythmias precluding proper CMR image acquisition, including atrial fibrillation and frequent atrial or ventricular ectopy of \> 1 in 5 intrinsic ECG complexes
* Contraindications to cardiac magnetic resonance imaging including claustrophobia, pacemaker or ICD implantation, mechanical valve or other metallic implants
* Significant liver impairment
* Renal impairment (eGFR\<45 ml min -1), end stage renal failure on renal replacement therapy
* Anaemia (Hb\<10 g/dL)
* Psychosocial barriers to telemedicine adoption (screening for education level, dementia, substance abuse and other psychological disorders)
* Participants who cannot be followed up
* Participants not able or willing to consent for study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT02483494
Study Brief:
Protocol Section:
NCT02483494