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Radial vs. Femoral Access for Cardiac Catheterization Complications (REBIRTH Trial)
N/A
Recruiting
Led By Emmanouil Brilakis, MD, PhD
Research Sponsored by Minneapolis Heart Institute Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years and older
Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluations will occur up to 30 days
Awards & highlights
REBIRTH Trial Summary
This trial will compare radial access (entering through the wrist) with femoral access (entering through the groin) for cardiac catheterization in patients without ST-segment elevation acute myocardial infarction. The trial will also compare 18 vs 21 gauge needles in the femoral access group.
Who is the study for?
Adults over 18 eligible for cardiac catheterization via both radial and femoral access, who consent to participate. Suitable for those needing diagnostic angiography or urgent/elective PCI, but not for patients with recent oral anticoagulant use, peripheral arterial disease affecting access sites, limited life expectancy, certain heart conditions or procedures within the next month.Check my eligibility
What is being tested?
This phase IV trial compares two methods of accessing the heart during catheterization: through the wrist (radial access) and upper thigh (femoral access). Participants are randomly assigned to one method; those in the femoral group are further randomized to receive either a smaller (21 gauge) or larger (18 gauge) needle.See study design
What are the potential side effects?
Potential side effects include bleeding at the site where the catheter is inserted, discomfort or pain related to needle size in femoral access cases, possible vascular complications like bruising or clotting at either site.
REBIRTH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am scheduled for a heart artery exam due to chest pain, possibly with treatment.
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I can have a heart catheterization through my wrist or groin.
REBIRTH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluations will occur up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluations will occur up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
Secondary outcome measures
Contrast volume
Duration of hospital stay and frequency of same day discharge
Fluoroscopy Time
+14 moreREBIRTH Trial Design
2Treatment groups
Active Control
Group I: State-of-the-art femoral accessActive Control2 Interventions
Femoral access for cardiac catheterization. Femoral access will be obtained using state-of-the-art techniques (ultrasound and fluoroscopic guidance for arterial puncture, immediate femoral angiography after obtaining access and use of a vascular closure device whenever possible).
Group II: Radial accessActive Control1 Intervention
Radial access for cardiac catheterization. Radial access will be performed using ultrasound guidance and a micropuncture needle or catheter-over-needle system, as per the local standard of care.
Find a Location
Who is running the clinical trial?
Minneapolis Heart Institute FoundationLead Sponsor
29 Previous Clinical Trials
12,199 Total Patients Enrolled
Emmanouil Brilakis, MD, PhDPrincipal InvestigatorMinneapolis Heart Institute Foundation
2 Previous Clinical Trials
92 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I took blood thinners less than 24 hours before the procedure.I have a dialysis access point in my arm that can be used for a heart procedure.I had a procedure to open blocked arteries in my heart due to a severe heart attack.I am scheduled for a procedure to check my heart's function.I have a condition in my arteries that prevents doctors from accessing my veins.I have surgeries planned within 30 days after the initial procedure.I am scheduled for a follow-up heart procedure within 30 days.I am scheduled for a procedure that requires two artery entries.I am scheduled for a heart artery exam due to chest pain, possibly with treatment.I can have a heart catheterization through my wrist or groin.I have had bypass surgery using arteries from my chest.I need heart valve surgery within 30 days after my initial procedure.My blood clotting time is higher than normal due to warfarin.
Research Study Groups:
This trial has the following groups:- Group 1: State-of-the-art femoral access
- Group 2: Radial access
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate enrollment for this research endeavor?
"Affirmative. Clinicaltrials.gov records show that this clinical trial, initially posted on November 15th 2019 is actively recruiting patients and has been recently updated on June 27th 2022. A total of 3266 individuals are needed for the single-location study."
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