Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to find out whether fasting is necessary before urgent inpatient cardiac catheterizations. For patients presenting with urgent heart-related pain or even mild heart attacks, researchers want to know whether eating and drinking before their procedure improves comfort without raising the risk of complications. The study will answer: * Does eating and drinking before the procedure improve patient comfort? * Does it increase the risk of adverse events like vomiting, aspiration (food or liquid entering the lungs), breathing problems, or death, etc? Participants will be randomly assigned to either: * A standard fasting group (no food for 6 hours, no clear liquids for 2 hours), or * A no-fasting group (able to eat and drink as usual). Patients will complete brief surveys before the procedure to assess comfort and satisfaction. Researchers will also review medical records weekly and 30 days later to monitor for safety outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All scheduled urgent inpatient non-high risk cardiac catheterizations for worsening angina (cardiac chest pain or anginal equivalent), unstable angina, or non-high risk NSTEMI-NSTEMI's with GRACE score \<140 points) utilizing proceduralist guided sedation

Locations
United States
Florida
Tampa General Hospital
RECRUITING
Tampa
Contact Information
Primary
Samip Vasaiwala, MD
samipv@usf.edu
312-375-8104
Backup
USF Institutional Review Board
RSCH-IRB@usf.edu
Time Frame
Start Date: 2025-10-13
Estimated Completion Date: 2026-07
Participants
Target number of participants: 400
Treatments
Active_comparator: Fasting
Participants in this group will follow standard pre-procedural fasting guidelines: no solid food for at least 6 hours and no clear liquids for at least 2 hours before their cardiac catheterization or NPO at Midnight.
Experimental: Non-Fasting
Participants in this group will have no dietary restrictions before their cardiac catheterization and may eat and drink as they normally would.
Sponsors
Leads: University of South Florida

This content was sourced from clinicaltrials.gov