NCT06996639Recruiting
Breaking Fasts Ahead of Cardiac Caths
Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 13 Oct 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- University of South Florida
- Diseases
- Coronary artery disease
- NCT number
- NCT06996639
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 13 Oct 2025 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence of severe decompensated heart failure on presentation requiring BiPAP or mechanical intubation
- Acute hypoxic respiratory failure requiring \>6L Nasal Cannula Supplementation, BiPAP, or invasive ventilation
Lab values
- New ejection fraction less than 25%
Age
- Patients \<18 years old
Other
- 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
- Inability to consent
- Pregnant patients
- Need for general anesthesia
- Emergent interventions: STEMI/high risk NSTEMI
- Need for mechanical circulatory support-ECMO, Impella or intra-aortic balloon pump
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.