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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fasting is necessary before urgent heart procedures, specifically cardiac catheterizations. Researchers aim to determine if eating and drinking beforehand increases patient comfort without raising risks such as vomiting or breathing issues. Participants will join one of two groups: one that fasts and one that does not. Individuals experiencing worsening chest pain or who have had a mild heart attack and are scheduled for a non-high risk heart procedure might be eligible to join.

As an unphased trial, this study provides an opportunity to contribute to important research that could enhance patient comfort during heart procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for patients undergoing cardiac catheterization?

Research has shown that fasting can be safe for individuals with stable heart conditions. Some studies suggest that fasting might improve heart health by lowering blood pressure and cholesterol levels. However, other research highlights certain risks. For instance, consuming all meals within a short time frame, such as 8 hours a day, has been linked to a higher risk of heart-related deaths. Individuals should consider these mixed findings when contemplating fasting before medical procedures. Weighing the potential benefits and risks is crucial, especially for those with heart issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how fasting before cardiac catheterization might affect heart attack outcomes. Unlike standard treatments for myocardial infarction, which often rely on medications like antiplatelets and beta-blockers, this trial is investigating a simple change in dietary protocol. Fasting could potentially enhance procedural outcomes or recovery by reducing complications during the procedure. Researchers hope to find out if this dietary adjustment can offer a straightforward, non-invasive way to improve heart attack treatment.

What evidence suggests that fasting or non-fasting before cardiac catheterization could be effective for improving patient comfort and safety?

Research has shown that intermittent fasting might help lower risk factors for heart disease. Some studies suggest that fasting does not increase the risk of heart attacks and might even reduce it. However, strong evidence is lacking that fasting directly improves outcomes in urgent heart procedures like cardiac catheterizations. This trial will compare two groups: one will follow standard pre-procedural fasting guidelines, and the other will have no dietary restrictions before their cardiac catheterization. The researchers aim to determine if patients can eat and drink before such procedures without increasing risks like vomiting or breathing problems. The goal is to balance patient comfort and safety with or without fasting. ^{6 7 8 9 10}

Who Is on the Research Team?

Samip Vasaiwala, MD

Principal Investigator

USF Department of Internal Medicine; Division of Cardiovascular Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12289860/

Intermittent Fasting for the Prevention of Cardiovascular ... Previous pairwise meta-analysis studies have shown some promise for intermittent fasting in reducing risk factors for cardiovascular disease.

2. droracle.ai droracle.ai/articles/300291/is-intermittent-fasting-if-associated-with-an-increased-risk-of-myocardial-infarction-heart-attack

Is intermittent fasting (IF) associated with an increased risk ... Intermittent Fasting and Heart Attack Risk. Intermittent fasting does not increase the risk of heart attacks and may actually reduce ...

3. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013496.pub2/full

Intermittent fasting for the prevention of cardiovascular ... We wanted to find out whether intermittent fasting affected mortality, cardiovascular mortality, risk of stroke, heart attack or heart failure.

4. nature.com nature.com/articles/s41598-025-13032-0

The different effects of admission blood glucose levels on ... Patients with diabetes might experience mortality due to chronic complications such as cardiovascular disease or kidney failure, while non- ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.033568

Mortality Benefits of Cardiac Rehabilitation in Coronary ... Cardiac rehabilitation (CR) is a multicomponent intervention to reduce adverse outcomes from coronary artery disease, but its mechanisms are ...

6. newsroom.heart.org newsroom.heart.org/news/8-hour-time-restricted-eating-linked-to-a-91-higher-risk-of-cardiovascular-death

8-hour time-restricted eating linked to a 91% higher risk of ... People who followed a pattern of eating all of their food across less than 8 hours per day had a 91% higher risk of death due to cardiovascular ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12495073/

Review on the effects of fasting on cardiac patients - PMC Available data suggests that fasting in Ramadan is safe for stable cardiac patients, with improvements in BMI, lipid profiles, blood pressure, ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.123.010936

The Randomized Controlled INTERFAST-MI Trial Our results suggest that intermittent fasting after myocardial infarction may be safe and could improve left ventricular function after STEMI.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0011502924001044

Intermittent fasting and cardiovascular disease: A scoping ... A recent observational study indicates a 91 % increased risk of CVD mortality associated with IF compared to consuming meals throughout a 12- to 16-hour period.

10. keckmedicine.org keckmedicine.org/blog/intermittent-fasting-and-heart-health/

Intermittent Fasting and Heart Health Experts say losing weight is beneficial for heart health, but there is little research on the long-term impact of intermittent fasting.