Disease Characteristics of IR-CAD: a Case-control Study

Korábbi kezelés

• Previous enrollment in this study.

Más betegség

• Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
• Active acute or chronic infection (human immunodeficiency virus \[HIV\], tuberculosis, et al).
• Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
• Vital organ failure.
• Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
• Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.
  • Control group (AS-CAD patients):
  • The same as those for the case group (IR-CAD patients).

Egyéb

• Case group (IR-CAD patients):
• Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
• Life expectancy \< 1 year.
• Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents.
• In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
• Participation in another study within 30 days.
• Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).

• Case group (IR-CAD patients):
• 18 years of age or older, male or female.
• Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
• Prior history of coronary revascularization (PCI or coronary artery bypass graft \[CABG\]).
• Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.
• Hospitalization due to rapidly-progressive myocardial ischemia:
  • Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and
  • Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization.
• Angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
• Evidence of inflammation:
  • At least one of the indexes indicating active inflammation has ever been elevated (ESR, high-sensitivity C-reactive protein \[hs-CRP\], interleukin \[IL\]-6, tumor necrosis factor \[TNF\]-α, ferritin, et al); or
  • Established diagnosis of systemic autoimmune disease or systemic vasculitis; or
  • Receiving immunosuppressive therapy.
  • Control group (AS-CAD patients):
• ≥ 45 and \< 65 years of age (based on the age distribution of the patients currently enrolled in the IR-CAD cohort study), male or female.
• Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
• Currently, 12±6 months after the last PCI.
• Receiving standard treatment for secondary prevention of AS-CAD after the last PCI.
• Coronary angiography and/or optical coherence tomography (OCT) performed during the present hospitalization.
• No evidence of rapidly-progressive myocardial ischemia, which is defined as follows:
  • Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and
  • Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI.
• No angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.