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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Cardiac Catheterization; Percutaneous Coronary Intervention; Fasting

Treatments: Other: Oral intake allowed

Study type: Interventional

Funder types: Other

Identifiers

NCT04116346

APHP190397

Details and patient eligibility

About

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

Enrollment: 736 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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736 participants in 2 patient groups

Fasting group

No Intervention group

Description:

Fasting for both solids and fluids for up to 6 hours pre-procedure

Non Fasting group

Experimental group

Description:

Usual meal on the day of the procedure and allowed to drink as usual

Treatment:

Other: Oral intake allowed