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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT01288560
Eligibility Criteria:
Inclusion criteria:
* Age \>18 years
* Known or highly suspected coronary artery disease (CAD) documented by coronary angiography or by history of previous MI or evidence of moderate ischemia or scar based on prior imaging
* LV dysfunction most likely attributable to ischemic heart disease with EF \<45% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class II-IV symptoms within the past 12 months.
OR
LV dysfunction most likely attributable to ischemic heart disease with EF ≤30% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class I within the past 12 months
Exclusion criteria:
* Severe medical conditions that significantly affect the patient's outcome (eg. severe COPD, active metastatic malignancy) and would preclude revascularization.
* \< 4 weeks post ST segment elevation myocardial infarction (STEMI)
* Already identified as not suitable for revascularization;
* Emergency revascularization indicated
* Severe valvular heart disease requiring surgery
* Contraindications to CMR (eg metallic implant, claustrophobia, renal failure (GFR \<30 ml/min/1.73m2),). However patients with permanent pacemakers or implanted defibrillators or GFR \<30 ml/min/1.7m2, will be randomized only to standard imaging (SPECT) versus PET or entered into the registry if only 1 modality is available
* Pregnancy
* Potential for non compliance to tests involved in this protocol
* Incapacity to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01288560
Study Brief:
Protocol Section:
NCT01288560