FastingFANPRECCNCT03555500
Fasting or Non Fasting for Cardiac Catheterization
A study testing Non fasting in people with Fasting and Cardiac Catheterization, run by Blackpool Victoria Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasting, Cardiac Catheterization
- What is being tested?
- Non fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2017to 10 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients >18 years undergoing elective coronary angiography or angioplasty procedures
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR
Hesham Abdelaziz, Ph.D, +44(0)1253957790, hesham.abdelaziz@bfwhospitals.nhs.uk
About this study
Official title: Fasting Versus Non-fasting Prior To Elective Cardiac Catheterization
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.
Read the 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.
- 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 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
- Being tested
- Non fasting
- Keywords
- Fasting, Non fasting, Cardiac catheterization
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non fastingOther
Non fasting group is allowed for clear fluids and food up to the time of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours
Secondary outcomes (4)
Incidence of hypoglycaemia
Drop of Blood sugar < 3.6 mmol/l as assessed by finger prick test before the procedure.
Measured: 1 hour
Incidence of hypotension
Drop of SBP<90 mmHg and /or DBP<60 mmHg as measured by manual sphygmomanometer before the procedure.
Measured: 1 hour
Patient satisfaction
A questionnaire given to the patient after the procedure to assess their experience , symptoms and overall satisfaction with regard to the procedure. The questionnaire include a preset of yes/no question including feeling hungry, thirsty or lethargic before the procedure, feeling headache, nausea or vomited during or up to 1 hour after the procedure. then a final overall satisfaction score about the procedure today from 1- 5, with 1 being not satisfied and 5 being extremely satisfied.
Measured: 1 hour
chest infection
All patients will be contacted or reviewed in clinic to assess for chest infection
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start2 Nov 2017
- Primary completion15 Dec 2018 (estimated)
- Study completion10 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blackpool Victoria Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Abdelaziz, Blackpool Victoria Hospital
- Investigators
- Hesham abdelaziz, Ph.D, Principal investigator, Blackpool Victoria Hospital -UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555500
- Sponsor's protocol ID
- 215149
- Acronym
- FANPRECC
- Status last verified
- Jun 2018
- First submitted
- 10 May 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24438649Association 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.
PubMed 20642539Rosengarten 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
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.
PubMed 14584013Kwon 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.
PubMed 21415144Hamid 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.
PubMed 24522621
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting Versus Non-fasting Prior To Elective Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT03555500
- Acronym / sponsor ID
- FANPRECC / 215149
- Conditions
- Fasting, Cardiac Catheterization
- Keywords
- Fasting, Non fasting, Cardiac catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Blackpool Victoria HospitalUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 10 Mar 2019 (estimated)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Non fastingClear fluids and food up to the time of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients >18 years undergoing elective coronary angiography or angioplasty procedures
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non fastingNon fasting group is allowed for clear fluids and food up to the time of the procedure. | Other | Non fasting group |
Primary outcome
Composite incidence of nausea, vomiting, abdominal pain, emergency intubation and aspiration
Time frame: 8 hours
The incidence of any of nausea, vomiting, abdominal pain aspiration or emergency intubation during the procedure and up to 8 hours will be recorded.
4 secondary outcomes
Incidence of hypoglycaemia
Time frame: 1 hour
Incidence of hypotension
Time frame: 1 hour
Patient satisfaction
Time frame: 1 hour
chest infection
Time frame: At 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Background: PubMed 24438649Godwin 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.
- Background: PubMed 20642539Association 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.
- BackgroundRosengarten 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: PubMed 14584013Brady 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.
- Results publication: PubMed 21415144Kwon 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.
- Results publication: PubMed 24522621Hamid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hesham abdelaziz, Ph.D principal investigator
Blackpool Victoria Hospital -UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non fasting in people with Fasting and Cardiac Catheterization, run by Blackpool Victoria Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesham Abdelaziz, Ph.D (+44(0) 1253957790, hesham.abdelaziz@bfwhospitals.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of nausea, vomiting, abdominal pain, emergency intubation and aspiration (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555500, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.