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

NCT07150780 | Not Yet Recruiting DMC

• 1 other identifier: MHCIIR001-2025
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease; Cardiac Catheterization; Cardiac Diseases

Keywords

Cardiac catheterization; Fasting; Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• Patient Satisfaction

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

  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.

  From procedure start time to 48 hours post-procedure.

Study Arms (2)

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.

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

Interventions

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.

Non-fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Munson Medical Center: lead

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Fasting; Patient Satisfaction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Feeding Behavior; Behavior; Treatment Adherence and Compliance; Health Behavior

Central Study Contacts

Erik H Howell, MD, MSc

CONTACT

231-935-5800; ehowell2@mhc.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): February 10, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08