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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral intake allowed | Other | Oral intake (food and fluids) allowed up to the time of the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events linked to oral intake before cardiac procedure: vasovagal complications or nausea or vomiting or hypoglycemia |
| 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 days |
| Post procedural aspiration pneumonia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madjid BOUKANTAR, Doctor | Contact | 01 49 81 21 11 | madjid.boukantar@aphp.fr | |
| Anissa ZAROUR | Contact | 01 49 81 33 44 | anissa.zarour@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR | Créteil | 94010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38811102 | Derived | 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. |
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data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information
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Our study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms
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The investigating physician performing the interventional procedure and evaluating the safety judgment criteria will not be informed of the patient's randomization arm
- All patients will be contacted or reviewed in clinic to assess for chest infection |
| 7 days |
| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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