Breaking Fasts Ahead of Cardiac Caths

This study is looking at whether you need to fast (not eat or drink) before an urgent heart procedure called a cardiac catheterization. If you have stable angina, unstable angina, or a non-ST segment elevation MI (NSTEMI - a type of heart attack), you might be eligible. Researchers want to see if eating and drinking as usual before your procedure makes you more comfortable without increasing risks like vomiting or breathing problems. You would be randomly assigned to either a group that fasts as usual or a group that doesn't fast. The main goal is to see how satisfied and comfortable patients are before their procedure.

Study design
This is an interventional study that will enroll 400 participants. You will be randomly assigned to one of two groups: a standard fasting group or a non-fasting group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess patient satisfaction and comfort within one hour before the cardiac catheterization, and safety outcomes like 30-day mortality will also be observed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06996639

Breaking Fasts Ahead of Cardiac Caths

Recruiting
NAAges 18+InterventionalHealth services
University of South Florida
~400 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Non-FastingFasting

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pre-procedural patient satisfaction and comfort
Measured over Within one hour pre-cardiac catheterization
Stable Angina (SA)
Unstable Angina (UA)
NSTEMI - Non-ST Segment Elevation MI
1 sites across 1 states
Florida1
  • Samip Vasaiwala, MD · PRINCIPAL_INVESTIGATOR · USF Department of Internal Medicine; Division of Cardiovascular Sciences

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Eligibility criteria

Inclusion

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

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
  • Pre-procedural patient satisfaction and comfortWithin 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.