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

NCT ID: NCT02373527

Last Updated: 2019-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

619 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-18

Study Completion Date

2019-06-05

Brief Summary

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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

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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.

Conditions

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Chest Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard - Strict Fasting

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Non Fasting

No Fasting prior to catheterization. Usual meal on the day of the procedure and allowed to drink as usual.

Group Type EXPERIMENTAL

No Fasting prior to catheterization

Intervention Type OTHER

No restriction for oral intake

Interventions

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No Fasting prior to catheterization

No restriction for oral intake

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Guthrie Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Sporn, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Abhishek Mishra, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Locations

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Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1411-60

Identifier Type: -

Identifier Source: org_study_id

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