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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPre + RIPost | Experimental | Intervention: RIPre 200 mmHg + RIPost 200 mmHg |
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| RIPre + Sham | Experimental | Intervention: RIPre 200 mmHg + Sham 10 mmHg |
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| Sham + RIPost | Experimental | Intervention: Sham 10 mmHg + RIPost 200 mmHg |
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| Sham + Sham | Sham Comparator | Intervention: Sham 10 mmHg + Sham 10 mmHg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPre | Procedure | Preconditioning 200 mmHg x 5 minutes before procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac Troponin-T from baseline | within 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | within 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nakarin Sansanayudh, MD,PhD | Contact | +6627639300 | 93807 | dr_nakarin@hotmail.com |
| Kitcha Champasri, MD | Contact | +66897146999 | dr.kitcha@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nakarin Sansanayudh, MD,PhD | Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine | Recruiting | Bangkok | 10400 | Thailand |
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| Sham-Pre | Procedure | Sham 10 mmHg x 5 minutes before procedure |
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| RIPost | Procedure | Postconditioning 200 mmHg x 5 minutes after procedure |
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| Sham-Post | Procedure | Sham 10 mmHg x 5 minutes after procedure |
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| Major adverse cardiovascular events (MACE) in each intervention group |
MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure. |
| 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). | 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). | 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. | 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. | 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). | 6 months |