Breaking Fasts Ahead of Cardiac Caths

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.

• 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

• Pre-procedural patient satisfaction and comfort [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

• Time since last oral intake [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.
• Hypotension [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.
• Hyperglycemia [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.
• Hypoglycemia [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.
• New hypoxic respiratory failure [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.
• Aspiration pneumonia [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.
• New non-invasive or invasive ventilation [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.
• New intensive care unit (ICU) admission [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.
• Need for emergency surgical intervention [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.
• 30-day mortality [30 days post-procedure]: To be gathered by chart review 30 days post-procedure.
• Sedation use [During procedure]: Total volume (mg or mcg) of midazolam and fentanyl administered during the procedure, as documented in the procedural record.

Sex: All, ages: 18 Years to any

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

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• Samip Vasaiwala, MD, Principal investigator, USF Department of Internal Medicine; Division of Cardiovascular Sciences