Breaking Fasts Ahead of Cardiac Caths
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Non-Fasting
BehavioralNo pre-procedural fasting required; participants may eat and drink as usual.
Fasting
BehavioralStandard pre-procedural fasting (≥6 hours for solids, ≥2 hours for clear liquids) or "NPO at Midnight."
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: FastingActive comparator 1 intervention
Group B: Non-FastingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pre-procedural patient satisfaction and comfort
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.
Time frame
Within one hour pre-cardiac catheterizationSecondary outcomes
1
Time since last oral intake
Time (in minutes) between last oral intake (food or fluid) as self-reported on pre-procedural survey and start of cardiac catheterization.
Time frame
At time of procedure2
Hypotension
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.
Time frame
During procedure and up to 6 hours post-procedure3
Hyperglycemia
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.
Time frame
During or within 6 hours post-procedure4
Hypoglycemia
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 frame
Within 6 hours pre and post-procedureSponsors and contacts
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Source ClinicalTrials.gov