FastingTONICNCT04116346
Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events
A study testing Oral intake allowed in people with Fasting and Cardiac Catheterization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Traditionally, patients are asked to fast prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this. Hypothesis/Objective : To show that allowing unrestricted oral intake before a coronary interventional procedure is not inferior to imposing a pre-procedural… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasting, Cardiac Catheterization, Percutaneous Coronary Intervention
- What is being tested?
- Oral intake allowed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 736 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 7 Dec 2022
- 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
- Agreement to participate and signed informed consent after information
- Affiliation to Social Security System
Who cannot join
- Patient requiring fasting for another procedure
- Immediate coronary emergency (STEMI, very high risk NSTEMI)
- Patient under artificial nutrition
- Hemodynamic instability
- Patient under guardianship or curators
- Pregnant women, breast-feeding
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
About this study
Official title: Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events: Randomized Controlled Trial of Non-inferiority (TONIC)
Traditionally, patients are asked to fast prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this.
Hypothesis/Objective :
Read more
To show that allowing unrestricted oral intake before a coronary interventional procedure is not inferior to imposing a pre-procedural fasting period, in terms of adverse events, in patients requiring coronary angiography or a planned or semi-urgent percutaneous coronary intervention.
Method:
The study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms. The investigating physician performing the interventional procedure and evaluating the safety judgment criteria will not be informed of the patient's randomization arm. In order to keep the blind, the medical and paramedical staff of the interventional cardiology room will not inquire about the fasting status of patients included in the study.
Patients are randomized either to the pre-procedural fasting arm or to the absence of pre-procedural fasting.
- No intervention: Pre-procedural fasting is defined by the absence of ingestion of fluids or solid food for at least 6 hours before the examination.
- Experimental: free feeding and drinking until the procedure.
Patients are followed for 4 hours after the end of the procedure at the hospital for adverse events (vagal discomfort, nausea, vomiting or hypoglycaemia).
Then a follow-up will be done at day 7 after the procedure (by telephone for outpatients or discharged from the hospital and in the cardiology department for patients still hospitalized on D7) to look for the occurrence of acute renal failure or pneumonia
- Being tested
- Oral intake allowed
- Keywords
- Fasting, Cardiac Catheterization, Percutaneous coronary intervention
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral intake allowedOther
Oral intake (food and fluids) allowed up to the time of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Fasting group | No intervention | Fasting for both solids and fluids for up to 6 hours pre-procedure |
| Non Fasting group | Experimental | Usual meal on the day of the procedure and allowed to drink as usual Receives: Other: Oral intake allowed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events linked to oral intake before cardiac procedure: vasovagal complications or nausea or vomiting or hypoglycemia
- Vagal reaction is defined by the presence of at least two of the following criteria occurring during the procedure or closure of the arterial approach or during the post-procedural observation phase, in the absence of other explanations:
- nausea / vomiting, skin paleness, sweating
- decrease in systolic pressure <100mmHg (or 15% decrease in baseline if systolic blood pressure <100 mmHg baseline)
- decrease in heart rate below 60 bpm (or more than 15% decrease if basal heart rate is below 60bpm) .
- Nausea evaluated by interrogation; vomiting noted by the doctor or nurse
- Hypoglycemia defined by the measurement of a glycemia lower than or equal to 0.70 mg / dL. This measurement is performed in the examination room at the beginning and end of the procedure on blood taken from the arterial sheath.
Measured: 4 hours
Secondary outcomes (2)
Post procedural acute renal failure
Defined by a 25% increase in serum creatinine compared with basal level, or an increase in serum creatinine of more than 44 μmol/l in 3 days after injection of contrast medium
Measured: 5 days
Post procedural aspiration pneumonia
- All patients will be contacted or reviewed in clinic to assess for chest infection
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Dec 2019 (estimated)
- Primary completion7 Dec 2022 (estimated)
- Study completion7 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Model description
- Our study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 736 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116346
- Sponsor's protocol ID
- APHP190397
- Acronym
- TONIC
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information
Publications
Boukantar M, Chiaroni PM, Gallet R, Zamora P, Truong T, Mangiameli A, Rostain L, Tuffreau-Martin AS, Natella PA, Oubaya N, Teiger E. A Randomized Controlled Trial of Nonfasting vs Fasting Before Interventional Coronary Procedures: The TONIC Trial. JACC Cardiovasc Interv. 2024 May 27;17(10):1200-1210. doi: 10.1016/j.jcin.2024.03.033.
PubMed 38811102
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events: Randomized Controlled Trial of Non-inferiority (TONIC)
- ClinicalTrials.gov ID
- NCT04116346
- Acronym / sponsor ID
- TONIC / APHP190397
- Keywords
- Fasting, Cardiac Catheterization, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 736 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 7 Dec 2022 (estimated)
- Study completion
- 7 Dec 2022 (estimated)
- First posted
- 4 Oct 2019 (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.
Traditionally, patients are asked to fast prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this.
Hypothesis/Objective :
To show that allowing unrestricted oral intake before a coronary interventional procedure is not inferior to imposing a pre-procedural fasting period, in terms of adverse events, in patients requiring coronary angiography or a planned or semi-urgent percutaneous coronary intervention.
Method:
The study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms. The investigating physician performing the interventional procedure and evaluating the safety judgment criteria will not be informed of the patient's randomization arm. In order to keep the blind, the medical and paramedical staff of the interventional cardiology room will not inquire about the fasting status of patients included in the study.
Patients are randomized either to the pre-procedural fasting arm or to the absence of pre-procedural fasting.
- No intervention: Pre-procedural fasting is defined by the absence of ingestion of fluids or solid food for at least 6 hours before the examination.
- Experimental: free feeding and drinking until the procedure.
Patients are followed for 4 hours after the end of the procedure at the hospital for adverse events (vagal discomfort, nausea, vomiting or hypoglycaemia).
Then a follow-up will be done at day 7 after the procedure (by telephone for outpatients or discharged from the hospital and in the cardiology department for patients still hospitalized on D7) to look for the occurrence of acute renal failure or pneumonia
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Our study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Fasting group | No intervention | –Fasting for both solids and fluids for up to 6 hours pre-procedure |
| Non Fasting group | Experimental | Other: Oral intake allowedUsual meal on the day of the procedure and allowed to drink as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients >18 years undergoing elective coronary angiography or angioplasty procedures
- Agreement to participate and signed informed consent after information
- Affiliation to Social Security System
Key exclusion criteria (6 listed)
- Patient requiring fasting for another procedure
- Immediate coronary emergency (STEMI, very high risk NSTEMI)
- Patient under artificial nutrition
- Hemodynamic instability
- Patient under guardianship or curators
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 |
|---|---|---|
| Oral intake allowedOral intake (food and fluids) allowed up to the time of the procedure | Other | Non Fasting group |
Primary outcome
Adverse events linked to oral intake before cardiac procedure: vasovagal complications or nausea or vomiting or hypoglycemia
Time frame: 4 hours
* Vagal reaction is defined by the presence of at least two of the following criteria occurring during the procedure or closure of the arterial approach or during the post-procedural observation phase, in the absence of other explanations: * nausea / vomiting, skin paleness, sweating * decrease in systolic pressure <100mmHg (or 15% decrease in baseline if systolic blood pressure <100 mmHg baseline) * decrease in heart rate below 60 bpm (or more than 15% decrease if basal heart rate is below 60bpm) . * Nausea evaluated by interrogation; vomiting noted by the doctor or nurse * Hypoglycemia defined by the measurement of a glycemia lower than or equal to 0.70 mg / dL. This measurement is performed in the examination room at the beginning and end of the procedure on blood taken from the arterial sheath.
2 secondary outcomes
Post procedural acute renal failure
Time frame: 5 days
Post procedural aspiration pneumonia
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Derived from this study: PubMed 38811102Boukantar M, Chiaroni PM, Gallet R, Zamora P, Truong T, Mangiameli A, Rostain L, Tuffreau-Martin AS, Natella PA, Oubaya N, Teiger E. A Randomized Controlled Trial of Nonfasting vs Fasting Before Interventional Coronary Procedures: The TONIC Trial. JACC Cardiovasc Interv. 2024 May 27;17(10):1200-1210. doi: 10.1016/j.jcin.2024.03.033.
- Individual participant dataSharing planned: No. data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral intake allowed in people with Fasting and Cardiac Catheterization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 6 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 4 Oct 2019. 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 France. 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 Madjid BOUKANTAR, Doctor (01 49 81 21 11, madjid.boukantar@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events linked to oral intake before cardiac procedure: vasovagal complications or nausea or vomiting or hypoglycemia (time frame: 4 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 NCT04116346, which also lists 1 linked publication.
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 4 Oct 2019.