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NCT Number: NCT06996639

Breaking Fasts Ahead of Cardiac Caths

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.

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Key information

Conditions

Stable Angina (SA) Acute Coronary Syndrome Angina Pectoris Angina, Stable Angina, Unstable Behavior Cardiovascular Diseases Chest Pain Fasting Feeding Behavior Health Behavior Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Signs and Symptoms Treatment Adherence and Compliance Unstable Angina (UA) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location status: Recruiting

Location contact

Adam Fennell, MD

SUB_INVESTIGATOR

Afrin Naz, MD

SUB_INVESTIGATOR

Chirag Lodha, DO

SUB_INVESTIGATOR

Jacob Thomas, MD

SUB_INVESTIGATOR

Jason Lee, Medical Student

SUB_INVESTIGATOR

Julia Eazer, Medical Student

SUB_INVESTIGATOR

Katherine Achinger, Medical Student

SUB_INVESTIGATOR

Marilyn Joseph, APRN

SUB_INVESTIGATOR

Matthew Almonte, MD

SUB_INVESTIGATOR

Matthew Nalls, MD

SUB_INVESTIGATOR

Mishal Mumtaz, MD

SUB_INVESTIGATOR

Paul Slota, MD

SUB_INVESTIGATOR

Rahul Mhaskar, MPH, PhD

SUB_INVESTIGATOR

Samip Vasaiwala, MD

CONTACT

[email protected]

312-375-8104

Samip Vasaiwala, MD

PRINCIPAL_INVESTIGATOR

University of South Florida IRB

CONTACT

[email protected]

Victoria Pitenis, APRN

SUB_INVESTIGATOR

Vincent Sachs, MD

SUB_INVESTIGATOR

About this study

While pre-procedural fasting is a longstanding tradition in cardiac catheterization, there is limited evidence supporting its necessity in low-risk patients undergoing urgent procedures for acute coronary syndromes (ACS). Existing studies have lacked adequate recruitment of ACS patients, comprehensive demographic capture, and long-term outcomes.

This randomized clinical trial will enroll adult inpatients undergoing cardiac catheterization for worsening angina and low risk ACS (unstable angina, and non-high risk NSTEMI's) with planned moderate proceduralist-guided sedation. Participants will be randomized 1:1 to either standard fasting (≥6 hours for solids and ≥2 hours for clear liquids) or no fasting requirement.

The primary endpoint is a composite of patient-reported outcomes assessing comfort and satisfaction. Secondary outcomes focus on clinical safety metrics, such as hemodynamic instability, aspiration pneumonia, ICU admission, procedural sedation requirements, and 30-day mortality, etc.

Proceduralists will remain unblinded; however, outcome assessment and statistical analysis will be performed by blinded third-party personnel. This trial aims to provide high-quality data to assess the necessity and impact of fasting in this specific patient population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Fasting

Behavioral

No pre-procedural fasting required; participants may eat and drink as usual.

Fasting

Behavioral

Standard pre-procedural fasting (≥6 hours for solids, ≥2 hours for clear liquids) or "NPO at Midnight."

Primary outcomes

  1. Pre-procedural patient satisfaction and comfort

    Time frame: Within one hour pre-cardiac catheterization

    Patient satisfaction and comfort will be assessed using a six-item survey evaluating hunger, thirst, nausea, nervousness, anger, and weakness. Each item is rated on a 5-point Likert scale from 1 ("strongly disagree" = least discomfort) to 5 ("strongly agree" = most discomfort). The total score ranges from 6 (best possible comfort) to 30 (worst possible discomfort). Higher scores indicate greater overall discomfort.

Secondary outcomes

  1. Time since last oral intake

    Time frame: At time of procedure

    Time (in minutes) between last oral intake (food or fluid) as self-reported on pre-procedural survey and start of cardiac catheterization.

  2. Hypotension

    Time frame: During procedure and up to 6 hours post-procedure

    Number of individuals with an occurrence of systolic blood pressure <85 mmHg or mean arterial pressure (MAP) <65 mmHg during or within 6 hours after the procedure.

  3. Hyperglycemia

    Time frame: During or within 6 hours post-procedure

    Number of individuals with an occurrence of blood glucose >200 mg/dL during or within 6 hours after the procedure, based on point-of-care or laboratory testing.

  4. Hypoglycemia

    Time frame: Within 6 hours pre and post-procedure

    Number of individuals with an occurrence of blood glucose <70 mg/dL within 6 hours before, during, or after the procedure based on point-of-care or laboratory testing.

  5. New hypoxic respiratory failure

    Time frame: During or with 6 hours post-procedure, not present prior to catheterization.

    Number of individuals with the development of new hypoxia (SpO₂ <85% on room air or requiring supplemental oxygen >4 L/min) during or within 6 hours post-procedure, not present prior to catheterization.

  6. Aspiration pneumonia

    Time frame: Within 72 hours post-procedure, not present prior to catheterization.

    Number of individuals with a new diagnosis of aspiration pneumonia within 72 hours post-procedure, based on new pulmonary infiltrate on imaging plus clinical signs (e.g., cough, fever, hypoxia), not present prior to procedure.

  7. New non-invasive or invasive ventilation

    Time frame: During or within 24 hours post-procedure

    Number of individuals with the initiation of CPAP, BiPAP, or endotracheal intubation during the procedure or within 24 hours post-procedure.

  8. New intensive care unit (ICU) admission

    Time frame: Within 24 hours post-procedure

    Number of individuals with a new admission to an ICU within 24 hours post-procedure that was not planned prior to catheterization.

  9. Need for emergency surgical intervention

    Time frame: During or within 24 hours post-procedure

    Number of individuals with an unplanned surgical procedure initiated during or within 24 hours after catheterization as a result of a procedural complication.

  10. 30-day mortality

    Time frame: 30 days post-procedure

    To be gathered by chart review 30 days post-procedure.

  11. Sedation use

    Time frame: During procedure

    Total volume (mg or mcg) of midazolam and fentanyl administered during the procedure, as documented in the procedural record.

Study contacts

Contact information is provided by the study sponsor or research team.

Samip Vasaiwala, MD

CONTACT

[email protected]

312-375-8104

USF Institutional Review Board

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

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

Acronym: BACON-RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 30, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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