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Breaking Fasts Ahead of Cardiac Caths
Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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.
What is being tested
- Non-Fasting (behavioral)
- Fasting (behavioral)
Sponsor: University of South Florida · Participants: 400 · Started: Oct 13, 2025
Contact the study team
- Samip Vasaiwala, MD · Phone: 312-375-8104
Official record on ClinicalTrials.gov — NCT06996639
Locations in the U.S.
| Florida | Tampa General Hospital, Tampa |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.