An interventional study of Remote ischemic preconditioning and Control in Aortic Valve Stenosis, Renal Insufficiency and Contrast-induced Nephropathy, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-14.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Prevention
Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.
Exclusion Criteria:
This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles.
Procedure: Remote ischemic preconditioning
This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles.
Procedure: Control
Serial inflations and deflations as detailed in the arm/group descriptions
Serial inflations and deflations as detailed in the arm/group descriptions
Renal function as a measured by serum creatinine
Assess the effects on post procedure renal injury. Lab work will be obtained in the form of a basic metabolic panel evaluating the creatinine level. A baseline basic metabolic panel will be obtained prior to scheduled procedure to evaluate baseline renal function and then 48-72 hours post procedure, the optimal time to see the effects of contrast induced nephropathy to evaluate the degree of acute kidney injury. The baseline and post procedure measurements of renal function will be compared between both arms of the study.
Time frame: 48-72 hours
Clinical Outcomes
The patient's electronic medical record will be reviewed at 6 months post procedure. The investigators will be assessing renal function at 6 months if a creatinine (lab) was ordered by the primary provider for any reason.
Time frame: 6 months
Clinical Outcomes
The investigators will be reviewing the medical records of participants for evidence of post procedure adverse events including death, MI, stroke and hospital readmission
Time frame: 6 months
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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