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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01CX002045-01 | U.S. NIH Grant/Contract | View source |
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This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.
The RICH Trial is a prospective, multicenter, randomized clinical trial to determine the effect of remote ischemic preconditioning on contrast associated acute kidney injury, and to characterize the effect of remote ischemic preconditioning on brain natriuretic peptide, functional capacity at one month, and major adverse kidney events (persistent renal dysfunction, renal replacement therapy, and death) at three months in patients with congestive heart failure with reduced left ventricular ejection fraction undergoing coronary angiography and/or percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic preconditioning | Active Comparator | 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes |
|
| Sham remote ischemic preconditioning | Sham Comparator | 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Device | 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-associated acute kidney injury | The investigators define contrast-associated acute kidney injury as a relative increase in serum creatinine of 0.3mg/dl compared with initial creatinine at 48 hours time point after coronary angiography and/or PCI. The will obtain levels of serum creatinine at baseline, then at 24 and 48 hours time points. | 24 and 48 hours time points |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walk distance | At one month follow-up, 6 minute walk test will be used to determine total distance walked in 6 minutes. | 1 month |
| Major adverse kidney events | Persistent renal dysfunction, renal replacement therapy, and death will be assessed at 3 months (90 days) to determine major adverse kidney events (MAKE90). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oladipupo Olafiranye, MD MS | Contact | (214) 857-2923 | Oladipupo.Olafiranye@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Oladipupo Olafiranye, MD MS | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Recruiting | Pittsburgh | Pennsylvania | 15240 | United States |
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Eligible patients will be randomized to RIPC or sham-RIPC.
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|
| Sham remote ischemic conditioning | Device | 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control) |
|
|
| 3 months |
| Brain Natriuretic Peptide (BNP) | BNP is a hormone that is primarily secreted from the ventricular myocardium in response to hemodynamic stimuli such as ventricular volume expansion and pressure overload. The investigators will obtain levels of serum BNP at baseline, then at 24 and 48 hours. | 24 and 48 hours time points |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Recruiting | Dallas | Texas | 75216-7167 | United States |
|
| Hunter Holmes McGuire VA Medical Center, Richmond, VA | Recruiting | Richmond | Virginia | 23249-0001 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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