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NCT02373527 Clinical Trial

Can we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study

Chest Pain Clinical Trial

Official title:
Strict Versus No Fasting Prior to Cardiac Catheterization: A Prospective Evaluation of Safety and Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02373527
Other study ID # 1411-60
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 18, 2015
Est. completion date June 5, 2019

Study information
Verified date June 2019
Source The Guthrie Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 619
Est. completion date June 5, 2019
Est. primary completion date April 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No Fasting prior to catheterization
No restriction for oral intake

Locations
Country Name City State
United States Robert Packer Hospital Sayre Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia 72 hours
Secondary Patient Satisfaction score 72 hours
Secondary Total cost of hospitalization 72 hours
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