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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluations will occur up to 30 days for reporting.

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 more

REBIRTH 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.

0 / 3Eligibility criteria met

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

Radial Access Clinical Trial Eligibility Overview. Trial Name: NCT04077762 — N/A

Vascular Access Complications Research Study Groups: State-of-the-art femoral access, Radial access

Vascular Access Complications Clinical Trial 2023: Radial Access Highlights & Side Effects. Trial Name: NCT04077762 — N/A

Radial Access 2023 Treatment Timeline for Medical Study. Trial Name: NCT04077762 — N/A

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)

2019. "Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04077762.