Recruiting

Fasting vs. No-Fasting

Sponsor:

University of South Florida

Code:

NCT06996639

Conditions

Stable Angina (SA)

Unstable Angina (UA)

NSTEMI - Non-ST Segment Elevation MI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Fasting

Fasting

Study Details

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.

Conditions

Stable Angina (SA)

Unstable Angina (UA)

NSTEMI - Non-ST Segment Elevation MI

Study ID

NCT06996639

Start date

Oct 13, 2025

Status verified date

Dec, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Non-Fasting

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

Fasting

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Samip Vasaiwala, MD

312-375-8104samipv@usf.edu

USF Institutional Review Board

RSCH-IRB@usf.edu

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Samip Vasaiwala, MD

312-375-8104Samipv@usf.edu

University of South Florida IRB

RSCH-IRB@usf.edu

Principal Investigator:

Samip Vasaiwala, MD

More Information

Sponsor

University of South Florida

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Fasting
  • NPO
  • Cardiac Catheterization
  • ACS
  • Angina
  • Unstable Angina
  • Worsening Angina
  • Low Risk NSTEMI
  • NSTEMI
  • Acute Coronary Syndrome
  • Urgent Cardiac Catheterization
  • Patient satisfaction
  • Periprocedural care
  • Non-fasting
  • Safety outcomes
  • Pre-procedural protocol
  • Survey-based research

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-12-16.