Breaking Fasts Ahead of Cardiac Caths

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06996639
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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."

Study Details

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.

Key Dates

Start date
Oct 13, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Fasting
    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."
  • Experimental: Non-Fasting
    Participants in this group will have no dietary restrictions before their cardiac catheterization and may eat and drink as they normally would.

Primary Outcome Measure

Pre-procedural patient satisfaction and comfort [ Time Frame: Within one hour pre-cardiac catheterization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606
Samip Vasaiwala, MD
312-375-8104
University of South Florida IRB
Samip Vasaiwala, MD (PRINCIPAL_INVESTIGATOR)
Matthew Almonte, MD (SUB_INVESTIGATOR)
Afrin Naz, MD (SUB_INVESTIGATOR)
Adam Fennell, MD (SUB_INVESTIGATOR)
Mishal Mumtaz, MD (SUB_INVESTIGATOR)
Marilyn Joseph, APRN (SUB_INVESTIGATOR)
Vincent Sachs, MD (SUB_INVESTIGATOR)
Rahul Mhaskar, MPH, PhD (SUB_INVESTIGATOR)
Jason Lee, Medical Student (SUB_INVESTIGATOR)
Julia Eazer, Medical Student (SUB_INVESTIGATOR)
Katherine Achinger, Medical Student (SUB_INVESTIGATOR)
Victoria Pitenis, APRN (SUB_INVESTIGATOR)
Matthew Nalls, MD (SUB_INVESTIGATOR)
Chirag Lodha, DO (SUB_INVESTIGATOR)
Paul Slota, MD (SUB_INVESTIGATOR)
Jacob Thomas, MD (SUB_INVESTIGATOR)

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