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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

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

This is the only study on the registry with Munson Medical Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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)
05

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.

06

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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2025; primary completion for Sep 2027, 24 months later.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 24 months is below that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2025
First posted
Sep 2, 2025
StartEst.
Sep 10, 2025
Primary completionEst.
Sep 10, 2027
CompletionEst.
Feb 10, 2028
Last update
Sep 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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Discussion

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