An interventional study of Non-Fasting and Fasting in Stable Angina (SA), Unstable Angina (UA) and NSTEMI - Non-ST Segment Elevation MI, sponsored by University of South Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by University of South Florida · Not applicable, Interventional, and Health services research
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:
Participants will be randomly assigned to either:
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.
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.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 400 is above the median of 150 across 230 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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."
Behavioral: Fasting
Participants in this group will have no dietary restrictions before their cardiac catheterization and may eat and drink as they normally would.
Behavioral: Non-Fasting
No pre-procedural fasting required; participants may eat and drink as usual.
Standard pre-procedural fasting (≥6 hours for solids, ≥2 hours for clear liquids) or "NPO at Midnight."
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 catheterization
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 procedure
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-procedure
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-procedure
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-procedure
New hypoxic respiratory failure
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.
Time frame: During or with 6 hours post-procedure, not present prior to catheterization.
Aspiration pneumonia
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.
Time frame: Within 72 hours post-procedure, not present prior to catheterization.
New non-invasive or invasive ventilation
Number of individuals with the initiation of CPAP, BiPAP, or endotracheal intubation during the procedure or within 24 hours post-procedure.
Time frame: During or within 24 hours post-procedure
New intensive care unit (ICU) admission
Number of individuals with a new admission to an ICU within 24 hours post-procedure that was not planned prior to catheterization.
Time frame: Within 24 hours post-procedure
Need for emergency surgical intervention
Number of individuals with an unplanned surgical procedure initiated during or within 24 hours after catheterization as a result of a procedural complication.
Time frame: During or within 24 hours post-procedure
30-day mortality
To be gathered by chart review 30 days post-procedure.
Time frame: 30 days post-procedure
Sedation use
Total volume (mg or mcg) of midazolam and fentanyl administered during the procedure, as documented in the procedural record.
Time frame: During procedure
Plan to share: Yes — The de-identified individual participant data (IPD) dataset will include information necessary to support the primary and secondary outcome findings.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available beginning 3 months and ending 5 years after the publication of results.
Access criteria: De-identified individual participant data (IPD) will be made available only upon request by ICMJE-affiliated journal editors or peer reviewers during the manuscript review and publication process. Data will not be shared with other external researchers or institutions. The dataset will include information necessary to support the primary and secondary outcome findings. No open-access sharing is planned. Requests for IPD must be submitted directly to the principal investigator via email. A data sharing agreement will be required to ensure confidentiality and appropriate use. The study principal investigator and research team will review each request to confirm it originates from a journal editor or peer reviewer and that the purpose aligns with manuscript review or publication. Once approved, access will be provided via a secure, encrypted file transfer. All data will be de-identified in accordance with HIPAA standards, and no identifiers will be included.
Started Oct 2025 (actual). Primary completion is estimated for Jun 2026, 8 months after the start.
Of 65 non-industry interventional studies with no phase under Angina, Stable, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 8 months is below that.
Counting every sponsor, half of 76 studies reached it within 35 months; a quarter within 14 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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