Clinical trial NCT06996639: Breaking Fasts Ahead of Cardiac Caths
Official title: Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stable Angina (SA)
Unstable Angina (UA)
NSTEMI - Non-ST Segment Elevation MI
Keywords: Fasting
NPO
Cardiac Catheterization
ACS
Angina
Unstable Angina
Worsening Angina
Low Risk NSTEMI
NSTEMI
Acute Coronary Syndrome
Urgent Cardiac Catheterization
Patient satisfaction
Periprocedural care
Non-fasting
Safety outcomes
Pre-procedural protocol
Survey-based research
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pre-procedural patient satisfaction and comfort
timeFrame: Within one hour pre-cardiac catheterization
Secondary outcomes:
measure: Time since last oral intake
timeFrame: At time of procedure
measure: Hypotension
timeFrame: During procedure and up to 6 hours post-procedure
measure: Hyperglycemia
timeFrame: During or within 6 hours post-procedure
measure: Hypoglycemia
timeFrame: Within 6 hours pre and post-procedure
measure: New hypoxic respiratory failure
timeFrame: During or with 6 hours post-procedure, not present prior to catheterization.
measure: Aspiration pneumonia
timeFrame: Within 72 hours post-procedure, not present prior to catheterization.
measure: New non-invasive or invasive ventilation
timeFrame: During or within 24 hours post-procedure
measure: New intensive care unit (ICU) admission
timeFrame: Within 24 hours post-procedure
measure: Need for emergency surgical intervention
timeFrame: During or within 24 hours post-procedure
measure: 30-day mortality
timeFrame: 30 days post-procedure
measure: Sedation use
timeFrame: During procedure
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: USF Department of Internal Medicine; Division of Cardiovascular Sciences
name: Samip Vasaiwala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
citation: 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.
citation: 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.
citation: 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.