Coronary Artery DiseaseFAST CATHNCT07150780
Benefits of no Fasting Compared to Fasting Prior to Elective Cardiac Catheterization: A Single-center Randomized-controlled Trial
A study testing Pre-operative instructions to eat and drink at liberty in people with Coronary Artery Disease and Cardiac Catheterization, run by Munson Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cardiac Catheterization, Cardiac Diseases
- What is being tested?
- Pre-operative instructions to eat and drink at liberty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2025to 10 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Adults unable to consent
- Pregnant women
- Incarceration
- Non-English-speaking patients
- Inability to eat by mouth
- Patients requiring general anesthesia for cardiac catheterization
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- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Being tested
- Pre-operative instructions to eat and drink at liberty
- Keywords
- Cardiac catheterization, Fasting, Patient Satisfaction
- Medical subject headings
- Coronary Artery Disease, Heart Diseases, Fasting, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative instructions to eat and drink at libertyProcedure or surgery
Subjects will be instructed to eat and drink at liberty prior to their schedule elective cardiac catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | No intervention | 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. |
| Non-fasting | Experimental | Subjects will be instructed to continue to eat and drink according to their normal diet without restriction, prior to their cardiac catheterization. Receives: Procedure: Pre-operative instructions to eat and drink at liberty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Six-point ordinal scale response preoperative fasting questionnaire. Self-reported.
Measured: Immediate pre-procedure period, not more than four hours before procedure start-time.
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.
Measured: From procedure start time to 48 hours post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start10 Sep 2025 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Munson Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150780
- Sponsor's protocol ID
- MHCIIR001-2025
- Acronym
- FAST CATH
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07150780
- Acronym / sponsor ID
- FAST CATH / MHCIIR001-2025
- Keywords
- Cardiac catheterization, Fasting, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Munson Medical CenterUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | No intervention | –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. |
| Non-fasting | Experimental | Procedure: Pre-operative instructions to eat and drink at libertySubjects will be instructed to continue to eat and drink according to their normal diet without restriction, prior to their cardiac catheterization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Adults unable to consent
- Pregnant women
- Incarceration
- Non-English-speaking patients
- Inability to eat by mouth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative instructions to eat and drink at libertySubjects will be instructed to eat and drink at liberty prior to their schedule elective cardiac catheterization. | Procedure or surgery | Non-fasting |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative instructions to eat and drink at liberty in people with Coronary Artery Disease and Cardiac Catheterization, run by Munson Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik H Howell, MD, MSc (231-935-5800, ehowell2@mhc.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Immediate pre-procedure period, not more than four hours before procedure start-time.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.