NCT02373527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
619

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

March 18, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

4.1 years

First QC Date

February 23, 2015

Last Update Submit

June 10, 2019

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

  • Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia

    72 hours

Secondary Outcomes (2)

  • Patient Satisfaction score

    72 hours

  • Total cost of hospitalization

    72 hours

Study Arms (2)

Standard - Strict Fasting

NO INTERVENTION

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.

Non Fasting

EXPERIMENTAL

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

Other: No Fasting prior to catheterization

Interventions

No Fasting prior to catheterizationOTHER

No restriction for oral intake

Non Fasting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients

You may not qualify if:

  • Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery
  • Pregnant Women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Sporn, MD

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR

  • Abhishek Mishra, MD

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

February 27, 2015

Study Start

March 18, 2015

Primary Completion

April 12, 2019

Study Completion

June 5, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Locations

US(1)