Breaking Fasts Ahead of Cardiac Caths

NCT06996639 | Recruiting DMC

• 1 other identifier: STUDY007430
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Pre-procedural patient satisfaction and comfort

  Patient satisfaction and comfort will be assessed using a six-item survey evaluating hunger, thirst, nausea, nervousness, anger, and weakness. Each item is rated on a 5-point Likert scale from 1 ("strongly disagree" = least discomfort) to 5 ("strongly agree" = most discomfort). The total score ranges from 6 (best possible comfort) to 30 (worst possible discomfort). Higher scores indicate greater overall discomfort.

  Within one hour pre-cardiac catheterization

Secondary Outcomes (11)

• Time since last oral intake

  At time of procedure

• Hypotension

  During procedure and up to 6 hours post-procedure

• Hyperglycemia

  During or within 6 hours post-procedure

• Hypoglycemia

  Within 6 hours pre and post-procedure

• New hypoxic respiratory failure

  During or with 6 hours post-procedure, not present prior to catheterization.

Study Arms (2)

Fasting

ACTIVE COMPARATOR

Participants in this group will follow standard pre-procedural fasting guidelines: no solid food for at least 6 hours and no clear liquids for at least 2 hours before their cardiac catheterization or "NPO at Midnight."

Behavioral: Fasting

Non-Fasting

EXPERIMENTAL

Participants in this group will have no dietary restrictions before their cardiac catheterization and may eat and drink as they normally would.

Behavioral: Non-Fasting

Interventions

Non-Fasting BEHAVIORAL

No pre-procedural fasting required; participants may eat and drink as usual.

Non-Fasting

Fasting BEHAVIORAL

Standard pre-procedural fasting (≥6 hours for solids, ≥2 hours for clear liquids) or "NPO at Midnight."

Fasting

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28045707 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction; Fasting; Angina Pectoris; Acute Coronary Syndrome; Patient Satisfaction

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Feeding Behavior; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Samip Vasaiwala, MD

  USF Department of Internal Medicine; Division of Cardiovascular Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samip Vasaiwala, MD

CONTACT

312-375-8104; samipv@usf.edu

USF Institutional Review Board

CONTACT

RSCH-IRB@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 30, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available beginning 3 months and ending 5 years after the publication of results.
• Access Criteria: De-identified individual participant data (IPD) will be made available only upon request by ICMJE-affiliated journal editors or peer reviewers during the manuscript review and publication process. Data will not be shared with other external researchers or institutions. The dataset will include information necessary to support the primary and secondary outcome findings. No open-access sharing is planned. Requests for IPD must be submitted directly to the principal investigator via email. A data sharing agreement will be required to ensure confidentiality and appropriate use. The study principal investigator and research team will review each request to confirm it originates from a journal editor or peer reviewer and that the purpose aligns with manuscript review or publication. Once approved, access will be provided via a secure, encrypted file transfer. All data will be de-identified in accordance with HIPAA standards, and no identifiers will be included.

Locations

US (1)