Fasting for Myocardial Infarction

(BACON-RCT Trial)

Overseen By USF Institutional Review Board

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: High risk NSTEMI, Hemodynamic instability, Unstable arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Samip Vasaiwala, MD

Principal Investigator

USF Department of Internal Medicine; Division of Cardiovascular Sciences

Eligibility Criteria

This trial is for patients with stable angina or ischemic heart disease who are undergoing urgent inpatient cardiac catheterizations. Participants should not have any conditions that would make fasting unsafe or influence the study's results.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo cardiac catheterization with either standard fasting or no fasting protocol

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety outcomes such as aspiration pneumonia, sedation use, and 30-day mortality

30 days

Weekly reviews and 1 visit at 30 days post-procedure

Treatment Details

Interventions

• Fasting
• Non-Fasting

Trial Overview The trial is testing if it's okay for patients to eat and drink before a cardiac cath procedure, comparing those who fast as usual to those who don't. It aims to see if non-fasting affects comfort levels and risks of complications.

Participant Groups

Group I: Non-Fasting Experimental Treatment 1 Intervention

Participants in this group will have no dietary restrictions before their cardiac catheterization and may eat and drink as they normally would.

Group II: Fasting Active Control 1 Intervention

Participants in this group will follow standard pre-procedural fasting guidelines: no solid food for at least 6 hours and no clear liquids for at least 2 hours before their cardiac catheterization or "NPO at Midnight."

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+