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

Percutaneous Coronary Intervention Clinical Trial

— TONIC  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04116346
• Other study ID #: APHP190397
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 7, 2022

Study information

• Verified date: September 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Madjid BOUKANTAR, Doctor
• Phone: 01 49 81 21 11
• Email: madjid.boukantar[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 736
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Catheterization
• Fasting
• Percutaneous Coronary Intervention

Intervention

Other:
• Oral intake allowed
Oral intake (food and fluids) allowed up to the time of the procedure

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours
Secondary	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
Secondary	Post procedural aspiration pneumonia	- All patients will be contacted or reviewed in clinic to assess for chest infection	7 days