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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 for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty
randomized controlled trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPre + RIPost | Experimental | Intervention: RIPre 200 mmHg + RIPost 200 mmHg |
|
| RIPre + Sham | Experimental | Intervention: RIPre 200 mmHg + Sham 10 mmHg |
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| Sham + RIPost | Experimental | Intervention: Sham 10 mmHg + RIPost 200 mmHg |
|
| Sham + Sham | Sham Comparator | Intervention: Sham 10 mmHg + Sham 10 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPre | Procedure | Preconditioning 200 mmHg x 5 minutes before procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value | Within a period of 24 hours after contrast medium administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sCr and eGFR from baseline | Within a period of 24 hours after contrast medium administration | |
| Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group | MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack |
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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 |
| Pawit Pipatwattanakul, MD | Contact | +6613728821 | pa_wit@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nakarin Sansanayudh, MD,PhD | Phramongkutklao College of Medicine and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine | Recruiting | Bangkok | 10400 | Thailand |
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| RIPost | Procedure | Postconditioning 200 mmHg x 5 minutes after procedure |
|
| Sham-Pre | Procedure | Sham 10 mmHg x 5 minutes before procedure |
|
| Sham-Post | Procedure | Sham 10 mmHg x 5 minutes after procedure |
|
| Within a period of 6 months after contrast medium administration |
| Incidence(%) of CI-AKI in differrent subgroups of patient characteristics | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value. | Within a period of 24 hours after contrast medium administration |
| Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost | Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value | Within a period of 24 hours after contrast medium administration |
| Incidence(%) of MACCE in differrent subgroups of patient characteristics | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack | Within a period of 6 months after contrast medium administration |
| Incidence(%) of MACCE in patients with vs without RIPre and RIPost | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack | Within a period of 6 months after contrast medium administration |
| Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI | Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value within a period of 24 hours after contrast medium administration | Within a period of 6 months after contrast medium administration |