RECRUITING

Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial

Talk to us

Conditions

Acute Kidney InjuryHeart FailureContrast Induced NephropathyCoronary AngiographyPercutaneous Coronary InterventionContrast-induced acute kidney injuryCongestive heart failureCoronary artery diseaseRemote ischemic conditioningacute coronary syndromeMajor adverse kidney eventsIschemic preconditioning

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial

Quick Facts

Study Start:2021-11-01
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04982419

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years
  2. * Diagnosis of heart failure with reduced LVEF \<50%
  3. * Pre-procedure intravenous normal saline fluid restriction status
  4. * Society for Cardiovascular Angiography and Interventions (SCAI) AKI risk score (\>1%)
  5. * Referral for coronary angiogram and/or PCI
  6. * Suspected stable coronary artery disease or acute coronary syndrome
  1. * Inability to give informed consent
  2. * Unstable BP (SBP \> 200 or \<80 mmHg) at the time of enrolment
  3. * Upper limb peripheral arterial disease
  4. * Unavailability of at least one arm for RIPC/Sham-RIPC application
  5. * Kidney transplant
  6. * Renal disease requiring dialysis
  7. * Prior exposure to contrast media within 72hrs preceding coronary angiography
  8. * Pregnancy
  9. * Prisoner

Contacts and Locations

Study Contact

Oladipupo Olafiranye, MD MS
CONTACT
(214) 857-2923
Oladipupo.Olafiranye@va.gov

Principal Investigator

Oladipupo Olafiranye, MD MS
PRINCIPAL_INVESTIGATOR
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Locations (Sites)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Oladipupo Olafiranye, MD MS, PRINCIPAL_INVESTIGATOR, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2021-11-01
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

  • Contrast-induced acute kidney injury
  • Congestive heart failure
  • Contrast induced nephropathy
  • Coronary angiography
  • Percutaneous coronary intervention
  • Coronary artery disease
  • Remote ischemic conditioning
  • acute coronary syndrome
  • Acute kidney injury
  • Major adverse kidney events
  • Ischemic preconditioning

Additional Relevant MeSH Terms

  • Acute Kidney Injury
  • Heart Failure
  • Contrast Induced Nephropathy
  • Coronary Angiography
  • Percutaneous Coronary Intervention