Fasting Versus Nonfasting Before Cardiac Catheterization: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Muhammad Saad, Saad Ahmed Waqas, Jazza Aamir...
https://pubmed.ncbi.nlm.nih.gov/39613281/Actively Recruiting
Led by University of South Florida · Updated on 2025-12-16
400
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are studying whether fasting is necessary before urgent inpatient cardiac catheterizations in patients experiencing urgent heart-related pain or mild heart attacks. The trial aims to find out if eating and drinking before the procedure improves patient comfort without increasing risks such as vomiting, aspiration, breathing problems, or death. This randomized clinical trial focuses on adults undergoing urgent cardiac catheterization for worsening angina and low-risk acute coronary syndromes, with planned moderate sedation. Participants will be randomly assigned to one of two groups a standard fasting group that abstains from solid food for at least 6 hours and clear liquids for 2 hours before the procedure, or a no-fasting group that may eat and drink as usual. The study is open-label and non-blinded, with proceduralists aware of group assignment but outcome assessments conducted by blinded personnel. The trial will provide data on the necessity and impact of fasting in this patient population. During the study, participants will complete brief surveys assessing comfort and satisfaction within one hour before the procedure. Researchers will also monitor safety outcomes by reviewing medical records weekly and at 30 days after the procedure. Secondary outcomes include measures such as blood pressure stability, blood sugar levels, respiratory complications, ICU admissions, sedation use, and mortality within 30 days. The total participation duration includes the procedure and follow-up monitoring for up to 30 days.
CONDITIONS
Breaking Fasts Ahead of Cardiac Caths
S
Samip Vasaiwala, MD
U
USF Institutional Review Board
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University of South Florida
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Non-Fasting (Eat and Drink as Usual) | Standard Fasting (NPO at Midnight or ≥6h/2h) |
|---|---|---|
| What is this approach? | Participants are allowed to eat and drink as they normally would before cardiac catheterization, with no pre-procedural fasting required. | Participants follow standard pre-procedural fasting: typically, no solid food for at least 6 hours and no clear liquids for at least 2 hours before the catheterization, or 'NPO at midnight.' |
| Role in the trial | This is the experimental group in the randomized trial, assessing outcomes such as patient comfort and risk related to eating and drinking before the procedure. | This group serves as the control or active comparator, undergoing usual care fasting protocols to allow direct comparison with the experimental group. |
| Primary use in patients | Explored as an alternative to fasting, aiming to improve patient satisfaction and comfort without increasing risk during cardiac catheterization. | Standard practice intended to reduce the risk of aspiration and related complications during cardiac procedures under sedation. |
| How is it given or performed? | No restrictions are placed on food or drink. Participants consume meals and liquids as usual until the procedure. | Patients are instructed to avoid all solids for at least 6 hours and clear liquids for at least 2 hours (or NPO from midnight) before catheterization. |
| Evidence status for efficacy and safety | Randomized trials and meta-analyses suggest non-fasting does not increase risks such as aspiration, hypotension, need for intensive care, or mortality, compared to the fasting group; also associated with improved patient comfort and satisfaction. | Longstanding practice with established safety, but recent randomized trials and reviews indicate that fasting before cardiac catheterization may not further reduce complications compared to more liberal intake policies in non-high risk patients. |
| Important limitations or uncertainties | Although current evidence from randomized trials suggests non-fasting is not inferior to fasting, studies vary in patient risk profiles and procedural details. Further research is needed for high-risk and emergent cases, and in settings with different sedation protocols. | While fasting is standard and guideline-based, increasing evidence questions its necessity for all patients. Traditional fasting may reduce patient comfort without demonstrable improvement in procedural outcomes for stable, non-high risk patients. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the day of the cardiac catheterization procedure
Participants follow assigned fasting or non-fasting protocols before undergoing cardiac catheterization with proceduralist-guided moderate sedation.
1 pre-procedural visit and 1 procedure day visit
Duration - Up to 72 hours post-procedure
Participants are monitored for safety outcomes including respiratory status, hemodynamic stability, and any complications within 72 hours after the cardiac catheterization.
1 to 3 follow-up visits depending on clinical status
Duration - 30 days post-procedure
Participants are followed for 30-day mortality and other longer-term outcomes after the procedure.
1 follow-up contact or visit
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/38025651/University of South Florida
Lead Sponsor