Ischemic Reperfusion Injury
Conditions
Keywords
Ischemic Preconditioning, Postconditioning, Angioplasty
Brief summary
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.
Interventions
Sponsors
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for percutaneous coronary intervention (elective and emergency cases) * Age \> 18-year-old * Informed consent
Exclusion criteria
* Previous CABG * Previous PCI in 1 week / treatment with thrombolysis within 30 days * Peripheral arterial disease / A-V shunt of upper extremities (AVF for hemodialysis) * Paresis of upper limb * Unstable patient such as cardiogenic shock / vasopressor / IABP / cooling (hypothermia) * Fatal cardiac arrhythmia (VT / VF) * Chronic hypoxia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cardiac Troponin-T from baseline | within 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACE) in each intervention group | 6 months | MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure. |
| Incidence of myocardial injury in differrent subgroups of patient characteristics | within 24 hours | 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). |
| Incidence of myocardial injury in patients with vs. without RIPre and RIPost | 24 hours | 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). |
| Incidence of myocardial injury | within 24 hours | 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). |
| Incidence of MACE in patients with vs. without RIPre and RIPost | 6 months | 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. |
| Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury | 6 months | 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). |
| Incidence of MACE in differrent subgroups of patient characteristics | 6 months | 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. |
Countries
Thailand
Contacts
Primary ContactNakarin Sansanayudh, MD,PhD
Backup ContactKitcha Champasri, MD
Outcome results
None listed