FastingFORCENCT05133206
Fasting or Non-fasting Before Cardiac Catheterization
A study testing Advice on fasting before the procedure in people with Fasting and Coronary Artery Disease, run by Blackpool Victoria Hospital at 1 site in United Kingdom.
Trial summary
The investigators hypothesise that there is no increased risk of peri-procedural complications, accompanied by improved patient satisfaction among patients allowed to eat up to the point of coronary angiography/angioplasty compared to patients, kept nil by mouth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasting, Coronary Artery Disease, Procedural Complication
- What is being tested?
- Advice on fasting before the procedure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2022to Oct 2023
- 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 in the 2 months window from consent.
Who cannot join
- Patients undergoing other cardiac procedures simultaneously such as EP studies, pacing and structural heart disease intervention.
- Emergency primary percutaneous coronary intervention.
- Vulnerable groups (children under 18 years old, pregnancy, mental health problems that render them unable to give informed consent).
Trial locations and contacts
1 site in 1 country.
Maciej Debski, MD, PhD contact
United Kingdom1 site
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR
About this study
The investigators hypothesise that there is no increased risk of peri-procedural complications, accompanied by improved patient satisfaction among patients allowed to eat up to the point of coronary angiography/angioplasty compared to patients, kept nil by mouth. Therefore, the investigators aim to change the practice of fasting for all patients before elective catheterization procedures.
Consented patients will be randomised in a 1:1 ratio to either fasting (standard hospital fasting policy) or non-fasting (allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory).
Primary End Point will composite peri-procedural nausea, vomiting, pre-procedural hypotension, pre-procedural hypoglycemia, intra-procedural emergency endotracheal intubation and aspiration pneumonia. This will be calculated as the number of patients experiencing at least one event. Secondary end-points will include patient satisfaction questionnaire and the individual outcomes assessed in the primary end point.
Read the detailed description
Nil by mouth (NBM) has been the standard of care for cardiac catheterization since its inception. The associated vomiting was common with the first generation of radiocontrast materials that were almost toxic, and with the use of general anaesthesia. Induction of anaesthesia depresses the cough and swallow reflex, thus increasing the risk of aspiration. This is also true for deep sedation. However, the practice has largely changed nowadays, with cardiac catheterization procedures being done under local anaesthesia with anxiolytic sedatives often used peri-procedurally to achieve minimal sedation whereby verbal contact is maintained. Both the Royal College of Anaesthetists and the Royal College of Emergency Medicine state that fasting is not required for minimal or conscious sedation but does recommend fasting for general anaesthesia. There is only less than a 1% risk of needing emergency surgery for percutaneous coronary interventions (PCIs). The risk of developing pulmonary aspiration following emergency coronary artery bypass grafting (CABG) surgery or emergency direct current conversion (DC) in patients without pre-procedural fasting is in the order of 0.001%.
There was no evidence that the volume or pH of participants' gastric contents differ significantly between fasting and non-fasting populations, as shown by Brady et al. In addition, the overall incidence of nausea and vomiting was reported to be 1% before elective cerebral angiography in a study carried out by Kwon et al. with no significant difference between fasting and non-fasting groups.
A recently conducted a retrospective analysis of registry data for 1916 percutaneous coronary intervention (PCI) patients over a 3-year period. None of the patients was kept nil by mouth (NBM) pre-procedure, and no patients required immediate endotracheal intubation, nor did any develop aspiration pneumonia intra or post procedurally. Thus, they concluded in their observational study that patients undergoing PCI do not need to have fasted before their procedures.
The American Society of Anaesthesia guidelines discuss this extensively and have concluded that there is no strong relation between fasting, gastric volume, or risk of aspiration. In any case, the patients at highest risk for nausea and vomiting are those who present with ST-elevation myocardial infarction (STEMI), who are not fasting anyway, and the need for emergency intubation/CABG remains rare in these patients.
Prolonged unnecessary fasting can often leave patients dissatisfied and add to the discomfort and anxiety of waiting for a procedure. Patients may also choose to miss their usual medications on the morning of the procedure due to restrictions advised with oral intake, increasing the risk of complications such as poorly controlled hypertension and the associated peri-procedural complications.
There is also evidence that patients often choose to fast longer than advised by healthcare professionals. The reasons for this include: misunderstanding by the patient that a longer period of fasting may be more protective, apprehension and loss of appetite before an invasive procedure or practical problems with timing of the procedure. Many patients undergo prolonged periods of fasting before a procedure. While this is not usually a problem for young fit patients, many of the patients do not fall into this category. Many are elderly with multiple co-morbidities and thus run the risk of hypoglycaemia and lethargy.
Further consideration has to be that of patient flow through the cardiac unit. If patients have to be NBM for a certain period before cardiac catheterization, then it reduces the ability to fill lists at short notice if patients need to be cancelled. On the other hand, if the investigators can demonstrate that this period of NBM is unnecessary, the investigators could maximize the catheter lab work as a resource.
Finally, and probably most importantly, the investigators feel that the overall patient experience will be improved if patients are allowed to eat up to the point of procedure, decreasing the number of hungry, disgruntled patients who complain to nurses.
Our pilot study of 50 patients (25 patients in each group) showed that non-fasting before cardiac catheterization is a safe and feasible approach that carries no additional risk compared to the standard practice of fasting. There was no difference in the primary composite endpoint for safety between the fasting and non-fasting group (one patient in the fasting group developed nausea/vomiting during the procedure and none in the non-fasting group; 4% vs 0, p=0.31). Compared to the fasting group, the non-fasting group had more diabetic patients (4% vs 24%, p=0.009), higher admission blood sugar (7±3 mmol/L vs 5±1 mmol/L, p=0.01), and shorter duration between the last meal and the procedure (110±85 min vs 433±158, p=009). There was no statistically significant difference between the two groups regarding the patient questionnaire results, patient satisfaction score, incidence of hypotension or chest infection within 30 days.
In summary, though growing observational evidence suggests no benefit to fasting, there is no conclusive evidence derived from a robustly randomised controlled trial to support or oppose the continued use of pre-procedural fasting before cardiac catheterisation. This proposed trial aims to add to this body of evidence and clarify guidelines and recommendations pertaining to fasting.
- Being tested
- Advice on fasting before the procedure
- Keywords
- Fasting, Non-fasting, Cardiac catheterization
- Medical subject headings
- Fasting, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advice on fasting before the procedureOther
Patients are allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Non-Fasting | Experimental | Oral fluids and food up to the time of the procedure. Receives: Other: Advice on fasting before the procedure |
| Fasting | No intervention | Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure - current practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of nausea.
incidence of self-reported nausea measured on a binary scale (yes or no)
Measured: Within 4 hours after the procedure.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of vomiting.
Incidence of vomiting assessed on binary scale (yes or no).
Measured: Within 4 hours after the procedure.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of pre-procedural hypotension.
Pre-procedural hypotension (systolic blood pressure <90 mmHg and /or diastolic blood pressure < 60 mmHg as measured non-invasively by sphygmomanometer)
Measured: Within 2 hours before the procedure.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence pre-procedural hypoglycemia.
Incidence of hypoglycemia peri-procedure (blood sugar < 3.6 mmol/l) as assessed by finger prick test.
Measured: Within 2 hours before the procedure.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of emergency endotracheal intubation.
Incidence of emergency tracheal intubation for respiratory failure
Measured: During the procedure
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of aspiration pneumonia.
Clinically and radiologically(X-ray and /or CT-scan) confirmed aspiration pneumonia.
Measured: During the procedure
Secondary outcomes (1)
Patient satisfaction assessed by questionnaire using a binary score (YES or NO), qualitative assessment of free text comments and presence of other symptoms as listed in the Description
Questionnaire assessing the self-reported pre-procedural hunger, thirst/dry mouth, headache, weakness/lethargy, heartburn, dizziness, low mood/anxiety, ability to focus/stay mentally sharp and preferences regarding fasting on a binary scale (yes or no).
Measured: Within 4 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study startMar 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation will take place through a sealed envelope method controlled by the cardiac research team; patients will be allocated 1:1 to either fasting or non-fasting groups using random blocks of sizes 4, 6, and 8 to minimise imbalance in treatment groups and preserve blinding up until the point of randomisation. This information (whether fasting or not) will be relayed to the patient at the time of pre-procedure assessment. The people who collate the data (the cath lab team or research nurses) and the operator performing the procedure will be blinded to the patient allocation group and will not be involved in conducting the analysis. The treatment group will be relabelled before analysis (i.e. group A and group B for not-fasting and fasting, respectively).
- Masking
- None (open label)
- Enrolment
- 420 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 K Abdelaziz, MSc, PhD, Principal investigator, Lancashire Cardiac Centre, Blackpool Victoria Hospital, Blackpool, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133206
- Sponsor's protocol ID
- 303042
- Acronym
- FORCE
- Status last verified
- Dec 2021
- First submitted
- 9 Sep 2021
- Last updated
- 14 Dec 2021
- 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 24438649Brady 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 24522621Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Naidu SS, Abbott JD, Bagai J, Blankenship J, Garcia S, Iqbal SN, Kaul P, Khuddus MA, Kirkwood L, Manoukian SV, Patel MR, Skelding K, Slotwiner D, Swaminathan RV, Welt FG, Kolansky DM. SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):255-276. doi: 10.1002/ccd.29744. Epub 2021 May 19.
PubMed 33909349
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting or Non-fasting Before Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT05133206
- Acronym / sponsor ID
- FORCE / 303042
- Keywords
- Fasting, Non-fasting, Cardiac catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Blackpool Victoria HospitalUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Nov 2021 (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 investigators hypothesise that there is no increased risk of peri-procedural complications, accompanied by improved patient satisfaction among patients allowed to eat up to the point of coronary angiography/angioplasty compared to patients, kept nil by mouth. Therefore, the investigators aim to change the practice of fasting for all patients before elective catheterization procedures.
Consented patients will be randomised in a 1:1 ratio to either fasting (standard hospital fasting policy) or non-fasting (allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory).
Primary End Point will composite peri-procedural nausea, vomiting, pre-procedural hypotension, pre-procedural hypoglycemia, intra-procedural emergency endotracheal intubation and aspiration pneumonia. This will be calculated as the number of patients experiencing at least one event. Secondary end-points will include patient satisfaction questionnaire and the individual outcomes assessed in the primary end point.
Detailed description
Nil by mouth (NBM) has been the standard of care for cardiac catheterization since its inception. The associated vomiting was common with the first generation of radiocontrast materials that were almost toxic, and with the use of general anaesthesia. Induction of anaesthesia depresses the cough and swallow reflex, thus increasing the risk of aspiration. This is also true for deep sedation. However, the practice has largely changed nowadays, with cardiac catheterization procedures being done under local anaesthesia with anxiolytic sedatives often used peri-procedurally to achieve minimal sedation whereby verbal contact is maintained. Both the Royal College of Anaesthetists and the Royal College of Emergency Medicine state that fasting is not required for minimal or conscious sedation but does recommend fasting for general anaesthesia. There is only less than a 1% risk of needing emergency surgery for percutaneous coronary interventions (PCIs). The risk of developing pulmonary aspiration following emergency coronary artery bypass grafting (CABG) surgery or emergency direct current conversion (DC) in patients without pre-procedural fasting is in the order of 0.001%.
There was no evidence that the volume or pH of participants' gastric contents differ significantly between fasting and non-fasting populations, as shown by Brady et al. In addition, the overall incidence of nausea and vomiting was reported to be 1% before elective cerebral angiography in a study carried out by Kwon et al. with no significant difference between fasting and non-fasting groups.
A recently conducted a retrospective analysis of registry data for 1916 percutaneous coronary intervention (PCI) patients over a 3-year period. None of the patients was kept nil by mouth (NBM) pre-procedure, and no patients required immediate endotracheal intubation, nor did any develop aspiration pneumonia intra or post procedurally. Thus, they concluded in their observational study that patients undergoing PCI do not need to have fasted before their procedures.
The American Society of Anaesthesia guidelines discuss this extensively and have concluded that there is no strong relation between fasting, gastric volume, or risk of aspiration. In any case, the patients at highest risk for nausea and vomiting are those who present with ST-elevation myocardial infarction (STEMI), who are not fasting anyway, and the need for emergency intubation/CABG remains rare in these patients.
Prolonged unnecessary fasting can often leave patients dissatisfied and add to the discomfort and anxiety of waiting for a procedure. Patients may also choose to miss their usual medications on the morning of the procedure due to restrictions advised with oral intake, increasing the risk of complications such as poorly controlled hypertension and the associated peri-procedural complications.
There is also evidence that patients often choose to fast longer than advised by healthcare professionals. The reasons for this include: misunderstanding by the patient that a longer period of fasting may be more protective, apprehension and loss of appetite before an invasive procedure or practical problems with timing of the procedure. Many patients undergo prolonged periods of fasting before a procedure. While this is not usually a problem for young fit patients, many of the patients do not fall into this category. Many are elderly with multiple co-morbidities and thus run the risk of hypoglycaemia and lethargy.
Further consideration has to be that of patient flow through the cardiac unit. If patients have to be NBM for a certain period before cardiac catheterization, then it reduces the ability to fill lists at short notice if patients need to be cancelled. On the other hand, if the investigators can demonstrate that this period of NBM is unnecessary, the investigators could maximize the catheter lab work as a resource.
Finally, and probably most importantly, the investigators feel that the overall patient experience will be improved if patients are allowed to eat up to the point of procedure, decreasing the number of hungry, disgruntled patients who complain to nurses.
Our pilot study of 50 patients (25 patients in each group) showed that non-fasting before cardiac catheterization is a safe and feasible approach that carries no additional risk compared to the standard practice of fasting. There was no difference in the primary composite endpoint for safety between the fasting and non-fasting group (one patient in the fasting group developed nausea/vomiting during the procedure and none in the non-fasting group; 4% vs 0, p=0.31). Compared to the fasting group, the non-fasting group had more diabetic patients (4% vs 24%, p=0.009), higher admission blood sugar (7±3 mmol/L vs 5±1 mmol/L, p=0.01), and shorter duration between the last meal and the procedure (110±85 min vs 433±158, p=009). There was no statistically significant difference between the two groups regarding the patient questionnaire results, patient satisfaction score, incidence of hypotension or chest infection within 30 days.
In summary, though growing observational evidence suggests no benefit to fasting, there is no conclusive evidence derived from a robustly randomised controlled trial to support or oppose the continued use of pre-procedural fasting before cardiac catheterisation. This proposed trial aims to add to this body of evidence and clarify guidelines and recommendations pertaining to fasting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomisation will take place through a sealed envelope method controlled by the cardiac research team; patients will be allocated 1:1 to either fasting or non-fasting groups using random blocks of sizes 4, 6, and 8 to minimise imbalance in treatment groups and preserve blinding up until the point of randomisation. This information (whether fasting or not) will be relayed to the patient at the time of pre-procedure assessment. The people who collate the data (the cath lab team or research nurses) and the operator performing the procedure will be blinded to the patient allocation group and will not be involved in conducting the analysis. The treatment group will be relabelled before analysis (i.e. group A and group B for not-fasting and fasting, respectively).
| Arm | Type | Receives |
|---|---|---|
| Non-Fasting | Experimental | Other: Advice on fasting before the procedureOral fluids and food up to the time of the procedure. |
| Fasting | No intervention | –Clear fluids up to the time of the procedure and no food for at least 2 hours before the procedure - current practice. |
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 in the 2 months window from consent.
Key exclusion criteria (3 listed)
- Patients undergoing other cardiac procedures simultaneously such as EP studies, pacing and structural heart disease intervention.
- Emergency primary percutaneous coronary intervention.
- Vulnerable groups (children under 18 years old, pregnancy, mental health problems that render them unable to give informed consent).
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 |
|---|---|---|
| Advice on fasting before the procedurePatients are allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory. | Other | Non-Fasting |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of nausea.
Time frame: Within 4 hours after the procedure.
incidence of self-reported nausea measured on a binary scale (yes or no)
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of vomiting.
Time frame: Within 4 hours after the procedure.
Incidence of vomiting assessed on binary scale (yes or no).
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of pre-procedural hypotension.
Time frame: Within 2 hours before the procedure.
Pre-procedural hypotension (systolic blood pressure <90 mmHg and /or diastolic blood pressure < 60 mmHg as measured non-invasively by sphygmomanometer)
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence pre-procedural hypoglycemia.
Time frame: Within 2 hours before the procedure.
Incidence of hypoglycemia peri-procedure (blood sugar < 3.6 mmol/l) as assessed by finger prick test.
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of emergency endotracheal intubation.
Time frame: During the procedure
Incidence of emergency tracheal intubation for respiratory failure
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of aspiration pneumonia.
Time frame: During the procedure
Clinically and radiologically(X-ray and /or CT-scan) confirmed aspiration pneumonia.
1 secondary outcome
Patient satisfaction assessed by questionnaire using a binary score (YES or NO), qualitative assessment of free text comments and presence of other symptoms as listed in the Description
Time frame: Within 4 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- 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 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.
- Background: 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.
- Background: 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.
- Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Background: PubMed 33909349Naidu SS, Abbott JD, Bagai J, Blankenship J, Garcia S, Iqbal SN, Kaul P, Khuddus MA, Kirkwood L, Manoukian SV, Patel MR, Skelding K, Slotwiner D, Swaminathan RV, Welt FG, Kolansky DM. SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):255-276. doi: 10.1002/ccd.29744. Epub 2021 May 19.
- Association of Anaesthetists of Great Britain and Ireland. AAGBI Safety Guideline 2010.Link provided by the sponsor.
- 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.
Maciej Debski, MD, PhD contact
Hesham K Abdelaziz, MSc, PhD principal investigator
Lancashire Cardiac Centre, Blackpool Victoria Hospital, Blackpool, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advice on fasting before the procedure in people with Fasting and Coronary Artery Disease, 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 3 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 Dec 2021. 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 K Abdelaziz, MSc, PhD ((+44) 01253957761, hesham.abdelaziz@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of nausea. (time frame: Within 4 hours after the procedure.). The study lists 6 primary outcomes in all. 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 NCT05133206, 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 Dec 2021.