Myocardial IschemiaNCT00563238
Beta-blocker Before Extubation
A study testing Metoprolol in people with Myocardial Ischemia, run by Gregory A. Schmidt at 1 site in United States.
Trial summary
Silent myocardial ischemia is known to occur in the general medical intensive care unit population immediately following tracheal extubation. We believe these patients are at risk for primary cardiac events in the 4 hours immediately following extubation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Metoprolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2009
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult medical or cardiac intensive care unit patients on mechanical ventilation who have known coronary artery disease or have at least 2 of the following risk factors for coronary artery disease:
- Cigarette smoking
- Hypertension (BP 140/90 or antihypertensive medication)
- Low HDL-cholesterol (HDL-C) (<40 mg/dL [1.03 mmol/L])
- Family history of premature CHD (in male first degree relatives <55 years, in female first degree relative <65 years)
- Age (men 45 years, women 55 years)
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- Diabetes mellitus
- Symptomatic carotid artery disease
- Peripheral arterial disease
- Abdominal aortic aneurysm
Who cannot join
- Arterial hypotension, defined as mean arterial pressure < 60 mmHg or requiring any intravenous vasoactive medication.
- The presence of known reactive airway disease.
- Resting heart rate of <60 in the period prior to tracheal extubation..
- The presence of decompensated congestive heart failure, defined as requiring continuous infusion of an inotropic agent.
- Known hypersensitivity to beta-blockers or any other contraindication to their use.
- Subjects younger than 18 years of age.
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- Inability to obtain consent from the subject or the subjects authorized representative.
- Pregnancy
- Digoxin therapy
- Current therapy with a beta-blocker
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Use of Prophylactic Beta Blockade to Prevent Peri-extubation Cardiac Ischemia and Congestive Heart Failure
Silent myocardial ischemia is known to occur in the general medical intensive care unit population immediately following tracheal extubation. We believe these patients are at risk for primary cardiac events in the 4 hours immediately following extubation. Metoprolol is a selective beta-1 antagonist, with little to no beta-2 activity at low and moderate doses. The cardioprotective effects of beta blockade have been well documented in randomized controlled trials. In patients undergoing extubation, prophylactic use of intravenous metoprolol may reduce post-extubation ischemia events as well as precursors of cardiogenic pulmonary edema (atrial and ventricular wall tension). Our primary hypothesis is that prophylactic metoprolol (titrated to reduce resting heart rate by at least 10%) prior to tracheal extubation will reduce the rate of ischemia as judged by ST segment analysis.
- Conditions
- Myocardial Ischemia
- Being tested
- Metoprolol
- Keywords
- Extubation
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Metoprolol administered intravenously in 2.5mg boluses until the resting heart rate falls by 10% from baseline to a maximum dose of 10mg, or until there is any apparent adverse reaction.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Metoprolol | Active comparator | Not described Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of ischemia as judged by ST segment analysis in the 4h following extubation
Measured: 4 hours
Secondary outcomes (3)
Rate-pressure product following extubation
Measured: 30min, 2h, 4h
Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation
Measured: 48h
Pro-BNP levels
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gregory A. Schmidt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gregory A. Schmidt, University of Iowa
- Investigators
- Gregory A Schmidt, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563238
- Sponsor's protocol ID
- 200708711
- Status last verified
- Feb 2017
- First submitted
- 21 Nov 2007
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Prophylactic Beta Blockade to Prevent Peri-extubation Cardiac Ischemia and Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00563238
- Acronym / sponsor ID
- 200708711
- Conditions
- Myocardial Ischemia
- Keywords
- Extubation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gregory A. SchmidtUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 26 Nov 2007 (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.
Silent myocardial ischemia is known to occur in the general medical intensive care unit population immediately following tracheal extubation. We believe these patients are at risk for primary cardiac events in the 4 hours immediately following extubation. Metoprolol is a selective beta-1 antagonist, with little to no beta-2 activity at low and moderate doses. The cardioprotective effects of beta blockade have been well documented in randomized controlled trials. In patients undergoing extubation, prophylactic use of intravenous metoprolol may reduce post-extubation ischemia events as well as precursors of cardiogenic pulmonary edema (atrial and ventricular wall tension). Our primary hypothesis is that prophylactic metoprolol (titrated to reduce resting heart rate by at least 10%) prior to tracheal extubation will reduce the rate of ischemia as judged by ST segment analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Metoprolol | Active comparator | Drug: Metoprolol |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult medical or cardiac intensive care unit patients on mechanical ventilation who have known coronary artery disease or have at least 2 of the following risk factors for coronary artery disease:
Key exclusion criteria (10 listed)
- Arterial hypotension, defined as mean arterial pressure < 60 mmHg or requiring any intravenous vasoactive medication.
- The presence of known reactive airway disease.
- Resting heart rate of <60 in the period prior to tracheal extubation..
- The presence of decompensated congestive heart failure, defined as requiring continuous infusion of an inotropic agent.
- Known hypersensitivity to beta-blockers or any other contraindication to their use.
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 |
|---|---|---|
| MetoprololMetoprolol administered intravenously in 2.5mg boluses until the resting heart rate falls by 10% from baseline to a maximum dose of 10mg, or until there is any apparent adverse reaction. | Drug | Metoprolol |
Primary outcome
The rate of ischemia as judged by ST segment analysis in the 4h following extubation
Time frame: 4 hours
3 secondary outcomes
Rate-pressure product following extubation
Time frame: 30min, 2h, 4h
Troponin T elevations, the incidence of cardiogenic edema, and the rate of reintubation
Time frame: 48h
Pro-BNP levels
Time frame: 30min
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
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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.
Gregory A Schmidt, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoprolol in people with Myocardial Ischemia, run by Gregory A. Schmidt 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 10 inclusion and 10 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: withdrawn, as of the sponsor's last update on 28 Feb 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
The rate of ischemia as judged by ST segment analysis in the 4h following extubation (time frame: 4 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 28 Feb 2017.