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

NCT04116346 | Unknown

• 1 other identifier: APHP190397
• Study Type: interventional
• Target: 736
• Locations: 1 country
• Sites: 1

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

Conditions

Fasting; Cardiac Catheterization; Percutaneous Coronary Intervention

Keywords

Fasting; Cardiac Catheterization; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Post procedural acute renal failure

  5 days

• Post procedural aspiration pneumonia

  7 days

Study Arms (2)

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

Other: Oral intake allowed

Interventions

Oral intake allowed OTHER

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

Non Fasting group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigating physician performing the interventional procedure and evaluating the safety judgment criteria will not be informed of the patient's randomization arm
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Our study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 4, 2019
• Study Start: December 1, 2019
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)