Fasting or Non Fasting for Cardiac Catheterization

NCT ID: NCT03555500

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2019-03-10

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.

Detailed Description

All patients to be admitted electively for coronary angiography or angioplasty will be given the opportunity to participate. An invitation letter together with patient information leaflet outlining the study will be sent along with the pre-procedure appointment letter to give the patient time to read and think about the study. Once at pre-procedure assessment clinic, the study will be explained further including potential risks and intended outcome and patients concerns will be addressed. Patient will be given the opportunity either to take part in the study or abstain and follow the standard procedure. If the patient agrees then they will sign the consent form and then be randomised in a 1:1 ratio to either the fasting or non-fasting group and be allocated a patient identification number. This will be done at the pre-procedure assessment clinic.

1. Fasting group (current practice): Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure.

2. Non Fasting Group: Clear fluids and food up to the time of the procedure. The pre procedure preparation will then be documented in the notes. Intention to treat analysis will be used to avoid the effects of crossover and dropout providing unbiased comparisons among the treatment groups.

Finally once the patient is ready for discharge they will be asked to complete an anonymous questionnaire relating to their experience and satisfaction.All patients will be contacted by phone on day 30 or the nearest working day thereafter to ensure no chest infections

Conditions

Fasting; Cardiac Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Fasting Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Non fasting group

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

Group Type: EXPERIMENTAL

Non fasting

Intervention Type: OTHER

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

Interventions

Non fasting

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blackpool Victoria Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hesham Abdelaziz

Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hesham abdelaziz, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Blackpool Victoria Hospital -UK

Locations

Blackpool Victoria Hospital

Blackpool, Lancashire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Hesham Abdelaziz, Ph.D

Role: CONTACT

hesham.abdelaziz@bfwhospitals.nhs.uk

+44(0) 1253957790

Jonas Eichhofer, Ph.D

Role: CONTACT

jonas.eichhofer@bfwhospitals.nhs.uk

+44(0)1253957791

Facility Contacts

Hesham Abdelaziz, Ph.D

Role: primary

hesham.abdelaziz@bfwhospitals.nhs.uk

+44(0)1253957790

References

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.

Reference Type: BACKGROUND

PMID: 24438649 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20642539 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 14584013 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21415144 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24522621 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

215149

Identifier Type: -

Identifier Source: org_study_id