Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)
University of South Florida
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.
Description
While pre-procedural fasting is a longstanding tradition in cardiac catheterization, there is limited evidence supporting its necessity in low-risk patients undergoing urgent procedures for acute coronary syndromes (ACS). Existing studies have lacked adequate recruitment of ACS patients, comprehensive demographic capture, and long-term outcomes. This randomized clinical trial will enroll adult inpatients undergoing cardiac catheterization for worsening angina and low risk ACS (unstable angina, and non-high risk NSTEMI's) with planned moderate proceduralist-guided sedation. Participants will b…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
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."
Location
- Tampa General HospitalTampa, Florida