Eating and drinking before urgent heart catheterization
Official title: Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)
Run by University of South Florida · NCT06996639 · Data updated 2026-11-12
This trial will try whether letting adults with worsening angina or low-risk NSTEMI eat and drink before an urgent inpatient cardiac catheterization improves comfort without raising the chance of complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Status | Recruiting |
| Started | October 13, 2025 |
| Main results expected | June 2026 |
| Study ends | July 2026 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT06996639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults hospitalized for worsening angina, unstable angina, or non-high-risk NSTEMI (GRACE score <140) scheduled for urgent cardiac catheterization with planned proceduralist-guided moderate sedation.
✕Probably not a fit
Patients with high-risk NSTEMI, hemodynamic instability, severe respiratory failure, need for general anesthesia or mechanical circulatory support, inability to consent, pregnancy, or age under 18 are excluded and unlikely to benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized inpatient trial that assigns adults with worsening angina, unstable angina, or non-high-risk NSTEMI (GRACE <140) to either standard fasting (≥6 hours for solids, ≥2 hours for clear liquids) or no fasting before a proceduralist-guided moderate sedation cardiac catheterization. The primary outcome is a composite of patient-reported comfort and satisfaction collected before the procedure, and secondary outcomes capture clinical safety events such as aspiration, hemodynamic instability, ICU admission, and 30-day mortality. Proceduralists are unblinded while outcome assessment and statistical analysis are performed by blinded third parties. Medical records are reviewed during hospitalization and at 30 days to capture safety endpoints.
Why it matters
Potential benefit: If successful, this could allow eligible patients to eat and drink before the procedure, improving comfort and reducing pre-procedure distress without increasing harm.
How similar studies have gone: Smaller or elective-case studies have suggested relaxed fasting may be safe in low-risk patients, but randomized data specifically in ACS inpatients are limited so this approach remains incompletely tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Tampa General Hospital
Tampa, Florida, United States Recruiting
Study contacts
- Principal investigator: Samip Vasaiwala, MD — USF Department of Internal Medicine; Division of Cardiovascular Sciences
- Study coordinator: Samip Vasaiwala, MD
- Email: samipv@usf.edu
- Phone: 312-375-8104
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.