Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02933892
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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
Chronic Kidney Disease Acute Kidney Injury Heart Disease 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2016
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.




Primary Outcome Measures :
  1. Incidence of CIN [ Time Frame: 3 days ]
  2. Incidence of CIN [ Time Frame: 30 days ]
  3. Need for dialysis [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933892


Contacts
Layout table for location contacts
Contact: Ami Knox ami.knox@ttuhsc.edu

Locations
Layout table for location information
United States, Texas
Texas Tech University Health Sciences Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Siva Iyer       siva.iyer@ttuhsc.edu   
Principal Investigator: Subasit Acharji, MD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Layout table for investigator information
Principal Investigator: Subasit Acharji, MD Texas Tech University Health Sciences Center
Publications:

Layout table for additonal information
Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02933892    
Other Study ID Numbers: L16-092
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, the research group may be potentially interested in sending data for further analyses.
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Heart Diseases
Urologic Diseases
Cardiovascular Diseases
Renal Insufficiency