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Not yet recruiting NCT07150780

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

No phase Interventional Coronary Artery Disease Cardiac Catheterization Cardiac Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pre-operative instructions to eat and drink at liberty.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Cardiac Catheterization, Cardiac Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Procedure Pre-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.

Primary outcome measures

  • Patient Satisfaction [Time frame: Immediate pre-procedure period, not more than four hours before procedure start-time.]
  • Pulmonary aspiration/pneumonitis/pneumonia [Time frame: From procedure start time to 48 hours post-procedure.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07150780 · MHCIIR001-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗