- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674451
Remote Ischemic Preconditioning to Prevent Contrast Nephropathy (RIPC-CIN)
Remote Ischemic Preconditioning to Prevent Contrast-induced Nephropathy in Patients With Stable and Unstable Coronary Disease Undergoing Coronary Angiography.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of coronary angiography, occurring in 10-50% of cases dependent on individual risk factors (JACC 2004; 44:1393). Multiple trials have found CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year mortality in patients with coronary artery disease (Clin Res Cardiol 2009;98:765, JACC 2004:44:1780, Ann Int Med 2009;150:170, JACC 2008; 51: 1419). The largest retrospective study of over 16,000 hospitalized patients exposed to iodinated contrast found an in-hospital mortality rate of 34% in subjects developing CIN versus 7% in matched control subjects (JAMA 1996;275:1489). Despite the incidence of CIN and the deleterious outcomes, few therapies exist to prevent CIN other than hydration and withdraw of nephrotoxic medications prior to coronary angiography.
Remote ischemic preconditioning (RIPC) is a protective response resulting from transient episodes of ischemia, followed by reperfusion, to vascular beds remote from the organ which will undergo the prolonged ischemic insult. Studies in humans indicate that RIPC decreases cardiac enzyme release, clinical events, and improves mortality in patients undergoing elective coronary bypass surgery (Circulation 2009;119:820; Lancet 2007;370:575, Lancet 2013; 382: 597). In addition to the cardio-protective effects of RIPC, a small, single center randomized trial showed a reduction in the incidence of contrast-medium induced nephropathy of approximately 30% in patients receiving RIPC prior to elective coronary angiography compared to a control population (Circulation 2012; 126:296). RIPC was safely performed in all of these studies by inflating a blood pressure cuff to supra-systolic levels (200mmHg) for 3 five minute episodes separated by 5 minutes of reperfusion.
RIPC is a well-tolerated, easily administered mechanism that may reduce the incidence of contrast-mediated nephropathy. However, additional and larger trials are needed to validate the use of RIPC in both elective and urgent coronary angiography in patients at risk for contrast-medicated nephropathy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing coronary angiography for stable or unstable coronary artery disease
- eGFR less than or equal to 60 mL/min/1.73 m2
Exclusion Criteria:
- Subjects with known upper extremity vascular disease
- Subjects with systolic blood pressure differential of 10 mmHg or higher in the upper extremities
- End stage renal disease on peritoneal or hemodialysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RIPC
Participants will receive remote ischemic preconditioning within one hour of coronary angiography.
This involves blood pressure cuff inflation to 200mmHG for three-5 minute periods, each separated by 5 minute intervals.
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Blood pressure cuff inflation to 200 mmHG for three 5-minute periods each separated by 5 minute intervals within 1 hour of planned coronary angiography.
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Sham Comparator: Controls
Participants will have routine blood pressure measurements will be obtained.
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Blood pressure cuff inflation to 200 mmHG for three 5-minute periods each separated by 5 minute intervals within 1 hour of planned coronary angiography.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute kidney injury
Time Frame: 48 hours after contrast administration
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Increase in serum creatinine greater than or equal to 0.05 mg/dL or a relative increase of greater than or equal to 25% of baseline.
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48 hours after contrast administration
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven P Schulman, M.D., Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00036762
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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