CClinicalTrials.gg
Not yet recruitingNCT07150780FAST CATHUpdated Sep 2, 2025

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

An interventional study of Pre-operative instructions to eat and drink at liberty in Coronary Artery Disease, Cardiac Catheterization and Cardiac Diseases, sponsored by Munson Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Munson Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Coronary Artery Disease
  • Cardiac Catheterization
  • Cardiac Diseases

Keywords

  • Cardiac catheterization
  • Fasting
  • Patient Satisfaction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • No intervention
    Fasting

    Prior to the subjects elective cardiac catheterization, they will be instructed to fast for 6 hours with the allowance of clear liquids up to 2 hours.

  • Experimental
    Non-fasting

    Subjects will be instructed to continue to eat and drink according to their normal diet without restriction, prior to their cardiac catheterization.

    Procedure: Pre-operative instructions to eat and drink at liberty

Interventions

  • ProcedurePre-operative instructions to eat and drink at liberty

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

05

What researchers measure

Primary outcomes

  1. Patient Satisfaction

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

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

  2. Pulmonary aspiration/pneumonitis/pneumonia

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

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07150780
Lead sponsor
Munson Medical Center
Responsible party
Sponsor
First posted
Sep 2, 2025
Start date
Sep 10, 2025 (estimated)
Primary completion
Sep 10, 2027 (estimated)
Completion
Feb 10, 2028 (estimated)
Last update
Sep 2, 2025

Study contacts

Erik H Howell, MD, MSc
Contact
ehowell2@mhc.net
231-935-5800

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion