Stable Angina (SA)BACON-RCTNCT06996639
Breaking Fasts Ahead of Cardiac Caths
A study testing Non-Fasting and Fasting in people with Stable Angina (SA) and Unstable Angina (UA), run by University of South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina (SA), Unstable Angina (UA), NSTEMI - Non-ST Segment Elevation MI
- What is being tested?
- Non-Fasting and Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
USF Institutional Review Board contact
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Samip Vasaiwala, MD, 312-375-8104, Samipv@usf.edu
University of South Florida IRB, RSCH-IRB@usf.edu
About this study
Official title: Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)
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:
Read more
- 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.
Read the 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.
- Being tested
- Non-Fasting, Fasting
- 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
- Medical subject headings
- Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction, Fasting, Angina Pectoris, Acute Coronary Syndrome, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-FastingBehavioural
No pre-procedural fasting required; participants may eat and drink as usual.
FastingBehavioural
Standard pre-procedural fasting (≥6 hours for solids, ≥2 hours for clear liquids) or "NPO at Midnight."
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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. Receives: Behavioral: Non-Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one hour pre-cardiac catheterization
Secondary outcomes (11)
Time since last oral intake
Time (in minutes) between last oral intake (food or fluid) as self-reported on pre-procedural survey and start of cardiac catheterization.
Measured: At time of procedure
Hypotension
Number of individuals with an occurrence of systolic blood pressure <85 mmHg or mean arterial pressure (MAP) <65 mmHg during or within 6 hours after the procedure.
Measured: During procedure and up to 6 hours post-procedure
Hyperglycemia
Number of individuals with an occurrence of blood glucose >200 mg/dL during or within 6 hours after the procedure, based on point-of-care or laboratory testing.
Measured: During or within 6 hours post-procedure
Hypoglycemia
Number of individuals with an occurrence of blood glucose <70 mg/dL within 6 hours before, during, or after the procedure based on point-of-care or laboratory testing.
Measured: Within 6 hours pre and post-procedure
New hypoxic respiratory failure
Number of individuals with the development of new hypoxia (SpO₂ <85% on room air or requiring supplemental oxygen >4 L/min) during or within 6 hours post-procedure, not present prior to catheterization.
Measured: During or with 6 hours post-procedure, not present prior to catheterization.
Aspiration pneumonia
Number of individuals with a new diagnosis of aspiration pneumonia within 72 hours post-procedure, based on new pulmonary infiltrate on imaging plus clinical signs (e.g., cough, fever, hypoxia), not present prior to procedure.
Measured: Within 72 hours post-procedure, not present prior to catheterization.
New non-invasive or invasive ventilation
Number of individuals with the initiation of CPAP, BiPAP, or endotracheal intubation during the procedure or within 24 hours post-procedure.
Measured: During or within 24 hours post-procedure
New intensive care unit (ICU) admission
Number of individuals with a new admission to an ICU within 24 hours post-procedure that was not planned prior to catheterization.
Measured: Within 24 hours post-procedure
Need for emergency surgical intervention
Number of individuals with an unplanned surgical procedure initiated during or within 24 hours after catheterization as a result of a procedural complication.
Measured: During or within 24 hours post-procedure
30-day mortality
To be gathered by chart review 30 days post-procedure.
Measured: 30 days post-procedure
Sedation use
Total volume (mg or mcg) of midazolam and fentanyl administered during the procedure, as documented in the procedural record.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start13 Oct 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stable Angina (SA)Studies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samip Vasaiwala, University of South Florida
- Investigators
- Samip Vasaiwala, MD, Principal investigator, USF Department of Internal Medicine; Division of Cardiovascular Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996639
- Sponsor's protocol ID
- STUDY007430
- Acronym
- BACON-RCT
- Status last verified
- Dec 2025
- First submitted
- 30 Apr 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data (IPD) dataset will include information necessary to support the primary and secondary outcome findings.
Publications
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.
PubMed 39807233Woods 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.
PubMed 38161168Saad 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.
PubMed 39613281Granger 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.
PubMed 14581255Practice 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.
PubMed 28045707Mishra 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.
PubMed 38025651Tamborrino 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.
PubMed 38336086
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Fasts Ahead of Cardiac Caths: an Open Label Non-Blinded RCT (BACON-RCT)
- ClinicalTrials.gov ID
- NCT06996639
- Acronym / sponsor ID
- BACON-RCT / STUDY007430
- Keywords
- Fasting, NPO, Cardiac Catheterization, ACS, Angina, Unstable Angina, Worsening Angina, Low Risk NSTEMI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | Active comparator | Behavioral: FastingParticipants 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." |
| Non-Fasting | Experimental | Behavioral: Non-FastingParticipants in this group will have no dietary restrictions before their cardiac catheterization and may eat and drink as they normally would. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-FastingNo pre-procedural fasting required; participants may eat and drink as usual. | Behavioural | Non-Fasting |
| FastingStandard pre-procedural fasting (≥6 hours for solids, ≥2 hours for clear liquids) or "NPO at Midnight." | Behavioural | Fasting |
Primary outcome
Pre-procedural patient satisfaction and comfort
Time frame: Within one hour pre-cardiac catheterization
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.
11 secondary outcomes
Time since last oral intake
Time frame: At time of procedure
Hypotension
Time frame: During procedure and up to 6 hours post-procedure
Hyperglycemia
Time frame: During or within 6 hours post-procedure
Hypoglycemia
Time frame: Within 6 hours pre and post-procedure
New hypoxic respiratory failure
Time frame: During or with 6 hours post-procedure, not present prior to catheterization.
Aspiration pneumonia
Time frame: Within 72 hours post-procedure, not present prior to catheterization.
New non-invasive or invasive ventilation
Time frame: During or within 24 hours post-procedure
New intensive care unit (ICU) admission
Time frame: Within 24 hours post-procedure
Need for emergency surgical intervention
Time frame: During or within 24 hours post-procedure
30-day mortality
Time frame: 30 days post-procedure
Sedation use
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 39807233Mitchell 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.
- Background: PubMed 38161168Woods 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.
- Background: PubMed 39613281Saad 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.
- Background: PubMed 14581255Granger 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.
- Background: PubMed 28045707Practice 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.
- BackgroundMishra 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: PubMed 38025651Ferreira 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.
- Background: PubMed 38336086Tamborrino 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.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data (IPD) dataset will include information necessary to support the primary and secondary outcome findings.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
USF Institutional Review Board contact
Samip Vasaiwala, MD principal investigator
USF Department of Internal Medicine; Division of Cardiovascular Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Fasting and Fasting in people with Stable Angina (SA) and Unstable Angina (UA), run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samip Vasaiwala, MD (312-375-8104, samipv@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-procedural patient satisfaction and comfort (time frame: Within one hour pre-cardiac catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06996639, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.