Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events (TONIC)

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 :

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 Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention; Fasting; Cardiac Catheterization
• Intervention / Treatment: Other: Oral intake allowed

• Study Type: Interventional
• Enrollment (Anticipated): 736
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madjid BOUKANTAR, Doctor; Phone Number: 01 49 81 21 11; Email: madjid.boukantar@aphp.fr
• Study Contact Backup: Name: Anissa ZAROUR; Phone Number: 01 49 81 33 44; Email: anissa.zarour@aphp.fr

Study Locations

• France
  • Créteil, France, 94010
    • Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Fasting group; Fasting for both solids and fluids for up to 6 hours pre-procedure
Experimental: Non Fasting group; Usual meal on the day of the procedure and allowed to drink as usual	Other: Oral intake allowed; Oral intake (food and fluids) allowed up to the time of the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, sweatingdecrease 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.	4 hours

Secondary Outcome Measures

Outcome Measure	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	- All patients will be contacted or reviewed in clinic to assess for chest infection	7 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 7, 2022
• Study Completion (Anticipated): December 7, 2022

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Fasting; Cardiac Catheterization
• Other Study ID Numbers: APHP190397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No