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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01559467
Eligibility Criteria:
Inclusion Criteria:
* Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac emergency department \<24 hours after symptom onset
* Increased levels of high-sensitive Troponin-T (\>14ng/L)
* Age \>18 years and \<85 years
* Willing and capable to give written informed consent
* Written informed consent
Exclusion Criteria:
* Ongoing severe ischemia requiring immediate invasive coronary angiography
* Shock (mean arterial pressure \< 60 mmHg) or severe heart failure (Killip Class ≥ III)
* ST-elevation myocardial infarction (ST-elevation in 2 contiguous leads: ≥0.2mV in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new left bundle branch block)
* Chest pain highly suggestive of non-cardiac origin:
* Acute aortic dissection
* Acute pulmonary embolism (high risk patient defined as Wells score \>6)
* Musculoskeletal or gastro-intestinal pain
* Other (pneumothorax, pneumonia, rib fracture, etc.)
* Previously known coronary artery disease, defined as:
* Any non-invasive diagnostic imaging test positive for coronary artery disease
* Coronary stenosis \>50% on any previous invasive coronary angiography or computed tomography angiography
* Documented previous myocardial infarction
* Documented previous coronary artery revascularization
* Known cardiomyopathy
* Pregnancy
* Life threatening arrhythmia on the cardiac emergency department or prior to presentation
* Tachycardia (≥100/bpm)
* Atrial fibrillation
* Angina pectoris secondary to anemia (\<5.6 mmol/L), untreated hyperthyroidism, aortic valve stenosis (aortic valve area ≤ 1.5 cm2), or severe hypertension (\>200/110 mmHg)
* Life expectancy \<1 year (malignancy, etc.)
* Contraindications to cardiovascular magnetic resonance imaging: metallic implant (vascular clip, neuro-stimulator, cochlear implant), pacemaker or implantable cardiac defibrillator, claustrophobia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01559467
Study Brief:
Protocol Section:
NCT01559467