This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
370
Department of Internal Medicine
Bangkok, Thailand
RECRUITINGChange in cardiac Troponin-T from baseline
Time frame: within 24 hours
Incidence of myocardial injury
Incidence of myocardial injury defined as \> 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin \> 20% in patients who have elevated baseline troponin (\>99 percentile upper reference limit).
Time frame: within 24 hours
Major adverse cardiovascular events (MACE) in each intervention group
MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
Time frame: 6 months
Incidence of myocardial injury in differrent subgroups of patient characteristics
Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine. Incidence of myocardial injury defined as \> 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin \> 20% in patients who have elevated baseline troponin (\>99 percentile upper reference limit).
Time frame: within 24 hours
Incidence of myocardial injury in patients with vs. without RIPre and RIPost
Myocardial injury defined as \> 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin \> 20% in patients who have elevated baseline troponin (\>99 percentile upper reference limit).
Time frame: 24 hours
Incidence of MACE in differrent subgroups of patient characteristics
Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine. MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sham 10 mmHg x 5 minutes after procedure
Time frame: 6 months
Incidence of MACE in patients with vs. without RIPre and RIPost
Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine. MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
Time frame: 6 months
Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury
Myocardial injury defined as \> 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin \> 20% in patients who have elevated baseline troponin (\>99 percentile upper reference limit).
Time frame: 6 months