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NCT Number: NCT07150780

Benefits of no Fasting Compared to Fasting Prior to Elective Cardiac Catheterization: A Single-center Randomized-controlled Trial

More than one million cardiac catheterizations (CCs) are performed annually in the United States and the majority are elective. Current guidelines recommend no fasting prior to elective CC, however recent studies suggest that eating and drinking as desired prior to elective CCs involving moderate sedation is safe.

This project will study the potential benefits of allowing patients to eat before elective CCs. Participants will be randomly divided into two groups. One group will receive pre-op instructions to fast, and the other group will be allowed to eat and drink as desired prior to their CC. Researchers will compare these groups with regards to patient satisfaction and respiratory complications.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to comply with all study procedures and remain in contact with the study team to complete study assessments for the duration of the study
  • Scheduled for an elective (non-urgent) cardiac catheterization
  • Age of 18 or older at the time of consent

Exclusion criteria

  • Adults unable to consent
  • Pregnant women
  • Incarceration
  • Non-English-speaking patients
  • Inability to eat by mouth
  • Patients requiring general anesthesia for cardiac catheterization
  • Inability to fast for at least 6 hours
  • Personal history of pulmonary aspiration, or other known cardiopulmonary anesthetic complication(s)
  • Urgent cardiac catheterization
  • Inability or unwillingness to comply with all study procedures
  • Previously enrolled in this study (patients may not be enrolled more than once for subsequent procedures)

Treatment and study plan

Pre-operative instructions to eat and drink at liberty

Procedure

Subjects will be instructed to eat and drink at liberty prior to their schedule elective cardiac catheterization.

Primary outcomes

  1. Patient Satisfaction

    Time frame: Immediate pre-procedure period, not more than four hours before procedure start-time.

    Six-point ordinal scale response preoperative fasting questionnaire. Self-reported.

  2. Pulmonary aspiration/pneumonitis/pneumonia

    Time frame: From procedure start time to 48 hours post-procedure.

    Indicated by an acute change in oxygen requirement noted in the procedure note or post-procedure progress note. Assessed by chart review. Present/absent.

Study contacts

Contact information is provided by the study sponsor or research team.

Erik H Howell, MD, MSc

CONTACT

[email protected]

231-935-5800

Sponsors and collaborators

Lead sponsor

Munson Medical Center

Other

Registry information

Official study title

Benefits of no FASTing Prior to Elective Cardiac CATHeterization (FAST CATH): A Single-center Randomized-controlled Trial Comparing a Non-fasting Pre-procedure Approach to the Standard of Care in Adults Undergoing Elective Cardiac Catheterization With Moderate Sedation

Acronym: FAST CATH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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