NCT03555500

Brief Summary

The current practice of fasting before cardiac catheterization is not based on any studies. If the procedure is to be delayed ( which is common due to busy catheterization lab), this could result in patient's dis-satisfaction and hypoglycemia. Occasionally, cancellation occur because patients are found to be non fasting ( not following the current protocol). The old data of fasting was extrapolated from procedure done under general anesthesia. Now days, cardiac catheterization is always done under local anesthesia and mild sedation. As a matter of fact, emergency cardiac catheterization done for heart attack patients carries more risk than elective one , and are still done without fasting with no reported complication rate like lung aspiration . The highest level of evidence to change the current practice comes from randomized control study. This study has been designed to challenge the current practice. The patients will be divided into 2 groups:

  • Fasting group (current practice): Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure.
  • Non Fasting Group: clear fluids and food and up to the time of the procedure The investigators' aim is to show that there is no difference with regards to potential complications between fasting (current practice) and non fasting (new practice) groups of patients with less incidence of hypoglycemia and hypotension in non fasting group. In addition, The investigators believe that patient satisfaction will be improved if patients are allowed to eat freely before the procedure and the catheter lab working ability will be maximized as the list can be filled promptly with patient on the waiting list (as fasting is no longer required) if a previously booked patient has to be cancelled in the last minute improving patient experience along with the associated financial benefits.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 2, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2019

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

May 10, 2018

Last Update Submit

June 13, 2018

Conditions

FastingCardiac Catheterization

Keywords

FastingNon fastingCardiac catheterization

Outcome Measures

Primary Outcomes (1)

  • Composite incidence of nausea, vomiting, abdominal pain, emergency intubation and aspiration

    The incidence of any of nausea, vomiting, abdominal pain aspiration or emergency intubation during the procedure and up to 8 hours will be recorded.

    8 hours

Secondary Outcomes (4)

  • Incidence of hypoglycaemia

    1 hour

  • Incidence of hypotension

    1 hour

  • Patient satisfaction

    1 hour

  • chest infection

    At 30 days

Study Arms (2)

Fasting Group

NO INTERVENTION

Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure.

Non fasting group

EXPERIMENTAL

Clear fluids and food up to the time of the procedure.

Other: Non fasting

Interventions

Non fastingOTHER

Non fasting group is allowed for clear fluids and food up to the time of the procedure.

Non fasting group

Eligibility Criteria

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

You may qualify if:

  • All patients \>18 years undergoing elective coronary angiography or angioplasty procedures

You may not qualify if:

  • Patient choice
  • Other cardiac procedures such as EP studies, pacing, structural heart disease intervention
  • Emergency PPCI
  • Patients already admitted in the hospital with UA / NSTEMI
  • Patients unable to give informed consent (vulnerable group)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blackpool Victoria Hospital

Blackpool, Lancashire, FY3 8NR, United Kingdom

RECRUITING

Related Publications (6)

  • Godwin SA, Burton JH, Gerardo CJ, Hatten BW, Mace SE, Silvers SM, Fesmire FM; American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2014 Feb;63(2):247-58.e18. doi: 10.1016/j.annemergmed.2013.10.015.

    PMID: 24438649BACKGROUND

  • Association of Anaesthetists of Great Britain and Ireland; Farling PA, Flynn PA, Darwent G, De Wilde J, Grainger D, King S, McBrien ME, Menon DK, Ridgway JP, Sury M, Thornton J, Wilson SR. Safety in magnetic resonance units: an update. Anaesthesia. 2010 Jul;65(7):766-70. doi: 10.1111/j.1365-2044.2010.06377.x.

    PMID: 20642539BACKGROUND

  • Rosengarten J, Ozkor M, Knight C. Fasting and cardiac catheterization should we be following the evidence. Controversies and Consensus in Imaging and Intervention (C2I2) 2007;V5:22-3

    BACKGROUND

  • Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. doi: 10.1002/14651858.CD004423.

    PMID: 14584013BACKGROUND

  • Kwon OK, Oh CW, Park H, Bang JS, Bae HJ, Han MK, Park SH, Han MH, Kang HS, Park SK, Whang G, Kim BC, Jin SC. Is fasting necessary for elective cerebral angiography? AJNR Am J Neuroradiol. 2011 May;32(5):908-10. doi: 10.3174/ajnr.A2408. Epub 2011 Mar 17.

    PMID: 21415144RESULT

  • Hamid T, Aleem Q, Lau Y, Singh R, McDonald J, Macdonald JE, Sastry S, Arya S, Bainbridge A, Mudawi T, Balachandran K. Pre-procedural fasting for coronary interventions: is it time to change practice? Heart. 2014 Apr;100(8):658-61. doi: 10.1136/heartjnl-2013-305289. Epub 2014 Feb 12.

    PMID: 24522621RESULT

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Hesham abdelaziz, Ph.D

    Blackpool Victoria Hospital -UK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesham Abdelaziz, Ph.D

CONTACT

+44(0) 1253957790hesham.abdelaziz@bfwhospitals.nhs.uk

Jonas Eichhofer, Ph.D

CONTACT

+44(0)1253957791jonas.eichhofer@bfwhospitals.nhs.uk

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
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

May 10, 2018

First Posted

June 13, 2018

Study Start

November 2, 2017

Primary Completion

December 15, 2018

Study Completion

March 10, 2019

Last Updated

June 14, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)