Breaking Fasts Ahead of Cardiac Caths

Not Applicable

Not yet recruiting

• Conditions: Stable Angina (SA); Unstable Angina (UA); NSTEMI - Non-ST Segment Elevation MI

• Registration Number: NCT06996639
• Lead Sponsor: University of South Florida

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Study Start: 2025-06
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States