Back to resultsCan we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study
Primary Purpose
Chest Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Fasting prior to catheterization
Sponsored by
About this trial
This is an interventional supportive care trial for Chest Pain
Eligibility Criteria
Inclusion Criteria:
- Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients
Exclusion Criteria:
- Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery
- Pregnant Women
- Prisoners
Sites / Locations
- Robert Packer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard - Strict Fasting
Non Fasting
Arm Description
No food after midnight the night before the procedure and will be allowed to drink clear liquids up to 2 hours prior to the procedure.
No Fasting prior to catheterization. Usual meal on the day of the procedure and allowed to drink as usual.
Outcomes
Primary Outcome Measures
Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia
Secondary Outcome Measures
Patient Satisfaction score
Total cost of hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02373527
Brief Title
Can we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study
Official Title
Strict Versus No Fasting Prior to Cardiac Catheterization: A Prospective Evaluation of Safety and Clinical Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 18, 2015 (Actual)
Primary Completion Date
April 12, 2019 (Actual)
Study Completion Date
June 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Guthrie Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.
Detailed Description
For years it has been common to have patients fast before a cardiac catheterization. It is believed that fasting may lower the risks of upset stomach, vomiting, and aspiration (stomach contents going to the lungs). New findings show that fasting before the procedure may not be needed. This study will look at the safety and possible benefits of not fasting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
619 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard - Strict Fasting
Arm Type
No Intervention
Arm Description
No food after midnight the night before the procedure and will be allowed to drink clear liquids up to 2 hours prior to the procedure.
Arm Title
Non Fasting
Arm Type
Experimental
Arm Description
No Fasting prior to catheterization. Usual meal on the day of the procedure and allowed to drink as usual.
Intervention Type
Other
Intervention Name(s)
No Fasting prior to catheterization
Intervention Description
No restriction for oral intake
Primary Outcome Measure Information:
Title
Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Patient Satisfaction score
Time Frame
72 hours
Title
Total cost of hospitalization
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients
Exclusion Criteria:
Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery
Pregnant Women
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Sporn, MD
Organizational Affiliation
The Guthrie Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abhishek Mishra, MD
Organizational Affiliation
The Guthrie Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Can we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study
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