RecruitingNot ApplicableNCT06996639

Breaking Fasts Ahead of Cardiac Caths

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


Sponsor

University of South Florida

Enrollment

400 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • 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

Exclusion Criteria13

  • High risk NSTEMI's defined as NSTEMI's with a GRACE score \>140 points
  • Hemodynamic instability (\<SBP 90)
  • Unstable arrythmias
  • Chest pain refractory to nitroglycerin drip
  • New ejection fraction less than 25%
  • Evidence of severe decompensated heart failure on presentation requiring BiPAP or mechanical intubation
  • Inability to consent
  • Patients \<18 years old
  • Pregnant patients
  • Need for general anesthesia
  • Acute hypoxic respiratory failure requiring \>6L Nasal Cannula Supplementation, BiPAP, or invasive ventilation
  • Emergent interventions: STEMI/high risk NSTEMI
  • Need for mechanical circulatory support-ECMO, Impella or intra-aortic balloon pump

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALNon-Fasting

No pre-procedural fasting required; participants may eat and drink as usual.

BEHAVIORALFasting

Standard pre-procedural fasting (≥6 hours for solids, ≥2 hours for clear liquids) or "NPO at Midnight."


Locations(1)

Tampa General Hospital

Tampa, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06996639


Related Trials