Chest PainNCT02373527
Can we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study
A study testing No Fasting prior to catheterization in people with Chest Pain, run by The Guthrie Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- No Fasting prior to catheterization
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 619 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2015to 5 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients
Who cannot join
- Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery
- Pregnant Women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strict Versus No Fasting Prior to Cardiac Catheterization: A Prospective Evaluation of Safety and Clinical Outcomes
The purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.
Read the detailed description
For years it has been common to have patients fast before a cardiac catheterization. It is believed that fasting may lower the risks of upset stomach, vomiting, and aspiration (stomach contents going to the lungs). New findings show that fasting before the procedure may not be needed. This study will look at the safety and possible benefits of not fasting.
- Conditions
- Chest Pain
- Being tested
- No Fasting prior to catheterization
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Fasting prior to catheterizationOther
No restriction for oral intake
| Study group | Role | What they receive |
|---|---|---|
| Standard - Strict Fasting | No intervention | No food after midnight the night before the procedure and will be allowed to drink clear liquids up to 2 hours prior to the procedure. |
| Non Fasting | Experimental | No Fasting prior to catheterization. Usual meal on the day of the procedure and allowed to drink as usual. Receives: Other: No Fasting prior to catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia
Measured: 72 hours
Secondary outcomes (2)
Patient Satisfaction score
Measured: 72 hours
Total cost of hospitalization
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study start18 Mar 2015
- Primary completion12 Apr 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Sporn, MD, Principal investigator, The Guthrie ClinicAbhishek Mishra, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373527
- Sponsor's protocol ID
- 1411-60
- Status last verified
- Jun 2019
- First submitted
- 23 Feb 2015
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strict Versus No Fasting Prior to Cardiac Catheterization: A Prospective Evaluation of Safety and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02373527
- Acronym / sponsor ID
- 1411-60
- Conditions
- Chest Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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 purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.
Detailed description
For years it has been common to have patients fast before a cardiac catheterization. It is believed that fasting may lower the risks of upset stomach, vomiting, and aspiration (stomach contents going to the lungs). New findings show that fasting before the procedure may not be needed. This study will look at the safety and possible benefits of not fasting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard - Strict Fasting | No intervention | –No food after midnight the night before the procedure and will be allowed to drink clear liquids up to 2 hours prior to the procedure. |
| Non Fasting | Experimental | Other: No Fasting prior to catheterizationNo Fasting prior to catheterization. Usual meal on the day of the procedure and allowed to drink as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients
Key exclusion criteria (3 listed)
- Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery
- Pregnant Women
- Prisoners
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 |
|---|---|---|
| No Fasting prior to catheterizationNo restriction for oral intake | Other | Non Fasting |
Primary outcome
Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia
Time frame: 72 hours
2 secondary outcomes
Patient Satisfaction score
Time frame: 72 hours
Total cost of hospitalization
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
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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. This study is not recruiting at the moment.
Daniel Sporn, MD principal investigator
The Guthrie Clinic
Abhishek Mishra, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Fasting prior to catheterization in people with Chest Pain, run by The Guthrie Clinic 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 3 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: finished, as of the sponsor's last update on 11 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2019.