Breaking Fasts Ahead of Cardiac Caths

Официальное название

Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)

Обзор

The goal of this clinical trial is to find out whether fasting is necessary before urgent inpatient cardiac catheterizations. For patients presenting with urgent heart-related pain or even mild heart attacks, researchers want to know whether eating and drinking before their procedure improves comfort without raising the risk of complications. The study will answer: * Does eating and drinking before the procedure improve patient comfort? * Does it increase the risk of adverse events like vomiting, aspiration (food or liquid entering the lungs), breathing problems, or death, etc? Participants will be randomly assigned to either: * A standard fasting group (no food for 6 hours, no clear liquids for 2 hours), or * A no-fasting group (able to eat and drink as usual). Patients will complete brief surveys before the procedure to assess comfort and satisfaction. Researchers will also review medical records weekly and 30 days later to monitor for safety outcomes.

Подробное описание

While pre-procedural fasting is a longstanding tradition in cardiac catheterization, there is limited evidence supporting its necessity in low-risk patients undergoing urgent procedures for acute coronary syndromes (ACS). Existing studies have lacked adequate recruitment of ACS patients, comprehensive demographic capture, and long-term outcomes.

This randomized clinical trial will enroll adult inpatients undergoing cardiac catheterization for worsening angina and low risk ACS (unstable angina, and non-high risk NSTEMI's) with planned moderate proceduralist-guided sedation. Participants will be randomized 1:1 to either standard fasting (≥6 hours for solids and ≥2 hours for clear liquids) or no fasting requirement.

The primary endpoint is a composite of patient-reported outcomes assessing comfort and satisfaction. Secondary outcomes focus on clinical safety metrics, such as hemodynamic instability, aspiration pneumonia, ICU admission, procedural sedation requirements, and 30-day mortality, etc.

Proceduralists will remain unblinded; however, outcome assessment and statistical analysis will be performed by blinded third-party personnel. This trial aims to provide high-quality data to assess the necessity and impact of fasting in this specific patient population.

Вмешательства

• Поведенческое Non-Fasting
  No pre-procedural fasting required; participants may eat and drink as usual.
• Поведенческое Fasting
  Standard pre-procedural fasting (≥6 hours for solids, ≥2 hours for clear liquids) or "NPO at Midnight."

Первичные конечные точки

• Pre-procedural patient satisfaction and comfort [Срок оценки: Within one hour pre-cardiac catheterization]

Вторичные конечные точки (11)

• Time since last oral intake [Срок оценки: At time of procedure]
• Hypotension [Срок оценки: During procedure and up to 6 hours post-procedure]
• Hyperglycemia [Срок оценки: During or within 6 hours post-procedure]
• Hypoglycemia [Срок оценки: Within 6 hours pre and post-procedure]
• New hypoxic respiratory failure [Срок оценки: During or with 6 hours post-procedure, not present prior to catheterization.]
• Aspiration pneumonia [Срок оценки: Within 72 hours post-procedure, not present prior to catheterization.]
• New non-invasive or invasive ventilation [Срок оценки: During or within 24 hours post-procedure]
• New intensive care unit (ICU) admission [Срок оценки: Within 24 hours post-procedure]
• Need for emergency surgical intervention [Срок оценки: During or within 24 hours post-procedure]
• 30-day mortality [Срок оценки: 30 days post-procedure]
• Sedation use [Срок оценки: During procedure]

Критерии участия

Критерии включения

• All scheduled urgent inpatient non-high risk cardiac catheterizations for worsening angina (cardiac chest pain or anginal equivalent), unstable angina, or non-high risk NSTEMI-NSTEMI's with GRACE score <140 points) utilizing proceduralist guided sedation

Критерии исключения

• High risk NSTEMI's defined as NSTEMI's with a GRACE score >140 points
• Hemodynamic instability (<SBP 90)
• Unstable arrythmias
• Chest pain refractory to nitroglycerin drip
• New ejection fraction less than 25%
• Evidence of severe decompensated heart failure on presentation requiring BiPAP or mechanical intubation
• Inability to consent
• Patients <18 years old
• Pregnant patients
• Need for general anesthesia
• Acute hypoxic respiratory failure requiring >6L Nasal Cannula Supplementation, BiPAP, or invasive ventilation
• Emergent interventions: STEMI/high risk NSTEMI
• Need for mechanical circulatory support-ECMO, Impella or intra-aortic balloon pump

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Tampa General Hospital — Tampa

Публикации

• Mitchell BK, Tomdio A, Pir MS, Mishra SK, Dayanand P, Bonnet G, Alu MC, Gertz ZM. A Randomized Trial of Cardiac Catheterization With Fasting Versus Liberal Oral Intake: The CALORI Trial. J Soc Cardiovasc Angiogr Interv. 2024 Oct 24;3(12):102291. doi: 10.1016/j.jscai.2024.102291. eCollection 2024 Dec. PMID 39807233
• Woods C, Wood M, Boylan A, Flanagan ME, Powers J. Fasting Versus a Heart-Healthy Diet Before Cardiac Catheterization: A Randomized Controlled Trial. Am J Crit Care. 2024 Jan 1;33(1):29-33. doi: 10.4037/ajcc2024115. PMID 38161168
• Saad M, Waqas SA, Aamir J, Sohail MU, Ansari I, Mohan A, Kumar V, Alraies MC. Fasting Versus Nonfasting Before Cardiac Catheterization: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Am J Cardiol. 2025 Mar 1;238:40-46. doi: 10.1016/j.amjcard.2024.11.030. Epub 2024 Nov 28. PMID 39613281
• Granger CB, Goldberg RJ, Dabbous O, Pieper KS, Eagle KA, Cannon CP, Van De Werf F, Avezum A, Goodman SG, Flather MD, Fox KA; Global Registry of Acute Coronary Events Investigators. Predictors of hospital mortality in the global registry of acute coronary events. Arch Intern Med. 2003 Oct 27;163(19):2345-53. doi: 10.1001/archinte.163.19.2345. PMID 14581255
• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):3 PMID 28045707
• Mishra A. Strict versus no fasting prior to cardiac catheterization: a prospective evaluation of safety and clinical outcomes. Can we safely have our patients eat with cardiac catheterization - nix or allow: the CHOW NOW study [abstract 11758].SCAI 2020 Virtual Scientific Sessions: Virtual Conference, May 14 to 16, 2020.
• Ferreira D, Hardy J, Meere W, Butel-Simoes L, McGee M, Whitehead N, Healey P, Ford T, Oldmeadow C, Attia J, Wilsmore B, Collins N, Boyle A. Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial). Eur Heart J Open. 2023 Oct 17;3(6):oead111. doi: 10.1093/ehjopen/oead111. eCollection 2023 Nov. PMID 38025651
• Tamborrino PP, Papi L, Michelotti L, Vitale C, Caravelli P, Petronio AS, Terlizzi E, Della Volpe L, Virlan M, Sardanelli A, Morganti R, De Caterina R. Do We Need Fasting Prior to Coronary Angiography? The CORO-NF Randomized Pragmatic Study. Am J Med. 2024 Jul;137(7):666-672. doi: 10.1016/j.amjmed.2024.01.024. Epub 2024 Feb 7. PMID 38336086

Идентификаторы

NCT: NCT06996639 · STUDY007430

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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