Eating and drinking before urgent heart catheterization

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of South Florida (other)
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT06996639 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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

Where this trial is running

Tampa, Florida

• 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

Conditions: Stable Angina, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI, Fasting, NPO, Cardiac Catheterization, ACS, Angina