Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06996639

Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded Randomized Clinical Trial

Led by University of South Florida · Updated on 2025-12-16

400

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Breaking Fasts Ahead of Cardiac Caths

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for urgent inpatient non-high risk cardiac catheterization for worsening angina, unstable angina, or non-high risk NSTEMI with GRACE score less than 140
  • Planned proceduralist-guided moderate sedation
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • High risk NSTEMI with GRACE score greater than 140
  • Hemodynamic instability with systolic blood pressure below 90
  • Unstable arrhythmias
  • Chest pain not responding to nitroglycerin drip
  • New ejection fraction less than 25%
  • Severe decompensated heart failure requiring BiPAP or mechanical intubation
  • Inability to provide consent
  • Patients younger than 18 years
  • Pregnant patients
  • Need for general anesthesia
  • Acute hypoxic respiratory failure requiring more than 6L nasal cannula, BiPAP, or invasive ventilation
  • Emergent interventions like STEMI or high risk NSTEMI
  • Need for mechanical circulatory support such as ECMO, Impella, or intra-aortic balloon pump

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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

Post-procedure Monitoring

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

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

Tampa General Hospital

Tampa, Florida, United States, 33606

Actively Recruiting

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Research Team

S

Samip Vasaiwala, MD

U

USF Institutional Review Board

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

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

Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration.

https://pubmed.ncbi.nlm.nih.gov/28045707

Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial).

David Ferreira, Jack Hardy, Will Meere...

https://pubmed.ncbi.nlm.nih.gov/38025651