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Coronary Angiogram and Right Heart Catheterization for Heart Disease (CALORI (NPO) Trial)

N/A
Recruiting
Led By Zachary Gertz, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Requiring a cardiac catheterization as per standard of care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours after the procedure
Awards & highlights

CALORI (NPO) Trial Summary

This trial will explore whether fasting (NPO) before cardiac catheterization is beneficial or harmful. Results will help determine if it's better to fast or not before the procedure.

Who is the study for?
This trial is for adults over 18 who need an elective cardiac catheterization with moderate sedation. It's not for emergencies, pregnant women, those with a BMI over 45, patients on mechanical heart support or other high-risk conditions, unstable heart disease, active stomach issues like nausea, chronic pain medication users, dementia sufferers, deep sedation cases or severe GERD.Check my eligibility
What is being tested?
The study is testing if fasting before a cardiac catheterization (coronary angiogram and right heart catheterization) affects patient satisfaction and immediate outcomes like nausea compared to not fasting. Patients are typically required to fast but this may increase discomfort and recovery time.See study design
What are the potential side effects?
Since the interventions are standard procedures rather than new medications or treatments being tested specifically for side effects in this trial; any potential side effects would be those commonly associated with coronary angiograms and right heart catheterizations under moderate sedation.

CALORI (NPO) Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I need a heart catheterization as recommended by my doctor.
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I am scheduled for a procedure that requires moderate sedation.

CALORI (NPO) Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (prior to procedure)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (prior to procedure) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intra- and post-procedural vomiting, aspiration, and intubation checklist
Pre-procedure wellness score (hunger, tiredness, anxiety, nausea)

CALORI (NPO) Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Non-Fasting groupExperimental Treatment2 Interventions
Participants will be allowed to eat and drink up to 1 hour prior to the procedure.
Group II: Fasting groupActive Control2 Interventions
Participant will be asked to fast at least 6 hours prior to the procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coronary angiogram
2017
Completed Phase 4
~3110
Right heart catheterization
2014
N/A
~60

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
691 Previous Clinical Trials
22,884,353 Total Patients Enrolled
Zachary Gertz, MDPrincipal InvestigatorVirginia Commonwealth University

Media Library

Coronary angiogram Clinical Trial Eligibility Overview. Trial Name: NCT05851872 — N/A
Heart Disease Research Study Groups: Fasting group, Non-Fasting group
Heart Disease Clinical Trial 2023: Coronary angiogram Highlights & Side Effects. Trial Name: NCT05851872 — N/A
Coronary angiogram 2023 Treatment Timeline for Medical Study. Trial Name: NCT05851872 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies to participate in this trial?

"Affirmative. As indicated on clinicaltrials.gov, the trial opened its doors to recruitment on March 1st 2023 and is currently welcoming participants - with a total of 400 people required from one location. This information was last updated on May 9th 2023."

Answered by AI

To what extent is this research being conducted with participants?

"Affirmative. Clinicaltrials.gov reports that this trial, which was initially uploaded on the 1st of March 2023, is actively recruiting participants. The study requires 400 patients to be recruited from one site."

Answered by AI
~0 spots leftby Apr 2024