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RADIAL-CKD: Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization

Sponsor
Texas Tech University Health Sciences Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02933892
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
74
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will conduct a randomized controlled trial that aims to compare the incidence of contrast-induced nephropathy between transradial- and transfemoral-access cardiac catheterization.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cardiac Catheterization
 Phase 4

Detailed Description

Cardiac catheterization is a medical procedure used to diagnose and treat heart conditions. Approaching the heart can be done by different access sites: via the femoral artery (transfemoral) or the radial artery (transradial). Transfemoral access (TFA) is the primary mode of arterial access. Several clinical trials have demonstrated the benefit of transradial over transfemoral approach. The primary advantage of transradial approach is a significant reduction of access-site complications. Chronic Kidney Disease (CKD) is a serious condition associated with premature mortality, decreased quality of life, and increased health-care expenditures. ). It is commonly found in patients with diabetes, hypertension, hyperlipidemia, coronary artery disease, or combinations of these risk factors. Coronary artery disease and CKD are often comorbid conditions seen in the cath lab. Cardiac catheterization is a mainstay of diagnosis and treatment for coronary artery disease and 58% of deaths in CKD are related to cardiovascular deaths. Patients with CKD and who undergo a cardiac catheterization are at risk for contrast-induced nephropathy (CIN) due to the dye used during the procedure.

The investigators will conduct a randomized controlled trial that aims to compare the incidence of CIN between transradial and transfemoral cardiac catheterization.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization, A Single Center Randomized Controlled Trial
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Transradial Access

Patients scheduled for cardiac catheterization will be randomly assigned to have the doctor insert the catheter via the arm access site (transradial access).

Procedure: Cardiac Catheterization
Cardiac catheterization is a diagnostic procedure used to treat and diagnose heart conditions.
Active Comparator: Transfemoral Access

Patients scheduled for cardiac catheterization will be randomly assigned to have the doctor insert the catheter via the inner thigh access site (transfemoral access).

Procedure: Cardiac Catheterization
Cardiac catheterization is a diagnostic procedure used to treat and diagnose heart conditions.

Outcome Measures

Primary Outcome Measures

  1. Incidence of CIN [3 days]

  2. Incidence of CIN [30 days]

  3. Need for dialysis [30 days]

Secondary Outcome Measures

  1. All cause mortality [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 88 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Patients scheduled to undergo non-emergent cardiac catheterization at University Medical Center Hospital, Lubbock, TX from January 2016 to January 2018. Emergent cardiac catheterizations will be defined as a catheterization scheduled < 24 hours from a cardiac event.

  2. Patients willing to be randomized to TFA or TRA procedure.

  3. Patients signed and dated the informed consent agreeing to participate in the study.

  4. Patients with chronic kidney disease, defined as eGFR = 15-59mL/min defined by the MDRD formula. (eGFR is a standard of care measurement for all patients undergoing coronary intervention.).

  5. Patients ages 18-88 years old.

Exclusion Criteria:

  1. Patients who have previously undergone a coronary artery bypass graft procedure.

  2. Patients with prior catheterization within the last 5 years.

  3. Women who are pregnant or expect to become pregnant. Pregnancy tests for women of childbearing potential (WOCHP) will be performed as standard of care.

  4. Patients with a history of cardiogenic shock.

  5. Children (under the age of 18).

  6. Medical, geographical, or social factors making study participation impractical, i.e. documented noncompliance, unable to return for follow-ups and lab draws, etc.

  7. A positive Allen's Test on the right radial artery.

  8. Any condition preventing TRA or TFA access.

  9. Contrast used within the previous 3 weeks.

  10. Allergy to contrast dye.

  11. Inability to successfully access the artery randomized to use.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Texas Tech University Health Sciences Center Lubbock Texas United States 79430

Sponsors and Collaborators

  • Texas Tech University Health Sciences Center

Investigators

  • Principal Investigator: Subasit Acharji, MD, Texas Tech University Health Sciences Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT02933892
Other Study ID Numbers:
  • L16-092
First Posted:
Oct 14, 2016
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Heart Diseases

Study Results

No Results Posted as of Nov 24, 2021