Clinical trial NCT04116346: Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasting
Cardiac Catheterization
Percutaneous Coronary Intervention
Keywords: Fasting
Cardiac Catheterization
Percutaneous coronary intervention
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 736
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms
Primary purpose: SUPPORTIVE_CARE

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events linked to oral intake before cardiac procedure: vasovagal complications or nausea or vomiting or hypoglycemia
timeFrame: 4 hours
Secondary outcomes:
measure: Post procedural acute renal failure
timeFrame: 5 days
measure: Post procedural aspiration pneumonia
timeFrame: 7 days
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Study officials:
References: