| NCT ID | NCT06996639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Stable Angina (SA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-10-13 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Samip Vasaiwala, MD
PRINCIPAL INVESTIGATOR
USF Department of Internal Medicine; Division of Cardiovascular Sciences
Frequently Asked Questions
Who can join the NCT06996639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stable Angina (SA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06996639 currently recruiting?
Yes, NCT06996639 is actively recruiting participants. Contact the research team at samipv@usf.edu for enrollment information.
Where is the NCT06996639 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT06996639 clinical trial?
NCT06996639 is sponsored by University of South Florida. The principal investigator is Samip Vasaiwala, MD at USF Department of Internal Medicine; Division of Cardiovascular Sciences. The trial plans to enroll 400 participants.