Acute Myocardial InfarctionPhase 1NCT00209144
Phase 1 Study of Potential Anti-Inflammatory Effects of Glucose Control During Acute Myocardial Infarction.
A Phase 1 study testing Intensive insulin therapy in people with Acute Myocardial Infarction, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to determine if intense control of high glucose levels in patients treated with angioplasty for heart attack has anti-inflammatory and anti-thrombotic effects. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Intensive insulin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2004to Dec 2006
- Phase
- Phase 1
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Patients to be treated with percutaneous coronary intervention for myocardial infarction.
Exclusion Criteria: MI > 6 hrs duration Thrombolytic therapy (within last 2 days) Recent inflammatory/infectious illness (last 2 weeks) Pregnancy Renal insufficiency (Cr > 2.0) Type I Diabetes Mellitus Initial BG >110 but <140 Enrollment in another research study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital
Atlanta, Georgia, 30322
Emory Crawford Long Hospital
Atlanta, Georgia, 30329
About this study
Official title: Effects of Intense Glycemic Control on Markers of Inflammation and Thrombosis in Patients Treated With Percutaneous Coronary Intervention for Acute Myocardial Infarction.
The purpose of this study is to determine if intense control of high glucose levels in patients treated with angioplasty for heart attack has anti-inflammatory and anti-thrombotic effects.
Read the detailed description
Two out of three heart attack patients have high blood sugar. Half of these patients have diabetes and the other half have what is called pre-diabetes, meaning that they have higher blood sugar than normal but not high enough to have diabetes. Over 40 million Americans have pre-diabetes.
For more than 70 years, doctors have known that patients with high blood sugar do not survive or recover from heart attacks as well as patients with normal blood sugar. Doctors have not figured out the reason for this difference.
The best treatment available for heart attacks is called angioplasty. Angioplasty means that doctors put a small balloon into a blocked blood vessel, blow up the balloon to open the blockage, and then insert a small wire tube called a stent to hold the blockage open. Blood thinners and other heart medicines are also given to these patients to help blood get through the blocked blood vessel. Angioplasty and these medicines have helped many people survive and recover from heart attacks. But even when doctors use these drugs, balloons and stents, patients who have high blood sugar still do worse than patients with normal blood sugar.
We want to figure out why high blood sugar is bad for patients with heart attacks. Past research tells us there might be two reasons. The first is that high blood sugar increases inflammation which is part of the body's natural response to heart attack. Inflammation is what causes a person's skin to turn hot and red after it is injured. Although inflammation is part of the body's natural healing process, too much inflammation can be harmful. We think that patients with high blood sugar during heart attacks have too much inflammation. The second reason why high blood sugar might be bad for heart attack patients is that high blood sugar makes blood thicker. When a blood vessel is blocked, thick blood makes it harder for the heart to get the blood flow it needs. This is why doctors use aspirin and other blood thinners when they treat patients with heart attacks.
The amount of inflammation and thickness in a person's blood can be measured in a laboratory. In this study, we want to measure the amount of inflammation and thickness in patients' blood to see if there is a difference between patients with normal blood sugar, patients with pre-diabetes, and patients with diabetes. If we can show that there is a difference, this will help us to understand why high blood sugar is bad for patients with heart attacks.
We also want to see if lowering a patient's high blood sugar is helpful during a heart attack. The standard therapy for lowering blood sugar in diabetic patients with heart attacks is to check their blood sugar four times each day while they are in the hospital, and to give them a shot of a medicine called insulin that helps bring the blood sugar level down if it is high. However, research tells us that this way of treating diabetic patients doesn't get their blood sugar low enough. Also, patients with pre-diabetes and patients who have diabetes but don't know it usually don't get any insulin, so their sugar levels are usually allowed to run high while they are in the hospital. In this study, we will treat half of diabetic and pre-diabetic patients the usual way and give the other half insulin through an IV for the first 24 hours that they are in the hospital. If we compare the inflammation and blood thickness between patients treated the usual way and patients treated with more insulin, we can figure out if lowering blood sugar more than usual is helpful to patients with heart attack.
If we can find out why high blood sugar is harmful to patients with heart attacks, and if we can show that treating these patients with more insulin than usual lessens these harmful effects, then we will be able to improve the way that these patients are treated. This could result in better survival and recovery for many heart attack patients.
All patients who volunteer for this study will get the best treatment available for heart attack- angioplasty, blood thinners, and the other heart medications that are usually given to these patients. Patients who have high blood sugar will be divided into two groups. One group will have their blood sugars measured and treated in the usual way. The other group will be treated with insulin run through an IV for 24 hours. After 24 hours, all patients will be treated in the usual way.
About one tablespoon of blood will be drawn from each patient at the time they sign up for the study and then 6, 12, 24, and 48 hours later. This blood will be used to test for inflammation and blood thickness.
The only ways in which patients who volunteer for this study will be treated differently from the standard of care are that they might receive more insulin than usual and they will have more blood drawn than usual. Giving extra insulin to these patients should not cause them harm, and may even help them. Since only about 5 tablespoons of extra blood will be drawn from each patient, this should not cause patients any harm.
Goals of this study
- To see what happens to blood inflammation and thickness in heart attack patients with normal blood sugar and compare this to patients with high blood sugar.
- To find out lowering patients' blood sugar levels more than we currently do will result in less blood inflammation and thickness.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Intensive insulin therapy
- Keywords
- Inflammation, Thrombosis, Hyperglycemia, Myocardial Infarction, Angioplasty
- Medical subject headings
- Inflammation, Thrombosis, Hyperglycemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive insulin therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Angioplasty with Insulin | Experimental | Coming in with acute infarct and received angioplasty with intensive insulin therapy Receives: Drug: Intensive insulin therapy |
| Angioplasty w/o Insulin | No intervention | Coming in with acute infarct and received angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin levels
Measured: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)
Secondary outcomes (2)
CRP level
Measured: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)
B-type natriuretic peptide levels.
Measured: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Morris, Emory University
- Investigators
- Douglas C Morris, MD, Principal investigator, Emory Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209144
- Sponsor's protocol ID
- 867-2004
- Other IDs
- 6-56553
- Status last verified
- Jun 2014
- First submitted
- 14 Sep 2005
- Last updated
- 16 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intense Glycemic Control on Markers of Inflammation and Thrombosis in Patients Treated With Percutaneous Coronary Intervention for Acute Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT00209144
- Acronym / sponsor ID
- 867-2004
- Conditions
- Acute Myocardial Infarction
- Keywords
- Inflammation, Thrombosis, Hyperglycemia, Myocardial Infarction, Angioplasty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Sep 2005 (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 determine if intense control of high glucose levels in patients treated with angioplasty for heart attack has anti-inflammatory and anti-thrombotic effects.
Detailed description
Two out of three heart attack patients have high blood sugar. Half of these patients have diabetes and the other half have what is called pre-diabetes, meaning that they have higher blood sugar than normal but not high enough to have diabetes. Over 40 million Americans have pre-diabetes.
For more than 70 years, doctors have known that patients with high blood sugar do not survive or recover from heart attacks as well as patients with normal blood sugar. Doctors have not figured out the reason for this difference.
The best treatment available for heart attacks is called angioplasty. Angioplasty means that doctors put a small balloon into a blocked blood vessel, blow up the balloon to open the blockage, and then insert a small wire tube called a stent to hold the blockage open. Blood thinners and other heart medicines are also given to these patients to help blood get through the blocked blood vessel. Angioplasty and these medicines have helped many people survive and recover from heart attacks. But even when doctors use these drugs, balloons and stents, patients who have high blood sugar still do worse than patients with normal blood sugar.
We want to figure out why high blood sugar is bad for patients with heart attacks. Past research tells us there might be two reasons. The first is that high blood sugar increases inflammation which is part of the body's natural response to heart attack. Inflammation is what causes a person's skin to turn hot and red after it is injured. Although inflammation is part of the body's natural healing process, too much inflammation can be harmful. We think that patients with high blood sugar during heart attacks have too much inflammation. The second reason why high blood sugar might be bad for heart attack patients is that high blood sugar makes blood thicker. When a blood vessel is blocked, thick blood makes it harder for the heart to get the blood flow it needs. This is why doctors use aspirin and other blood thinners when they treat patients with heart attacks.
The amount of inflammation and thickness in a person's blood can be measured in a laboratory. In this study, we want to measure the amount of inflammation and thickness in patients' blood to see if there is a difference between patients with normal blood sugar, patients with pre-diabetes, and patients with diabetes. If we can show that there is a difference, this will help us to understand why high blood sugar is bad for patients with heart attacks.
We also want to see if lowering a patient's high blood sugar is helpful during a heart attack. The standard therapy for lowering blood sugar in diabetic patients with heart attacks is to check their blood sugar four times each day while they are in the hospital, and to give them a shot of a medicine called insulin that helps bring the blood sugar level down if it is high. However, research tells us that this way of treating diabetic patients doesn't get their blood sugar low enough. Also, patients with pre-diabetes and patients who have diabetes but don't know it usually don't get any insulin, so their sugar levels are usually allowed to run high while they are in the hospital. In this study, we will treat half of diabetic and pre-diabetic patients the usual way and give the other half insulin through an IV for the first 24 hours that they are in the hospital. If we compare the inflammation and blood thickness between patients treated the usual way and patients treated with more insulin, we can figure out if lowering blood sugar more than usual is helpful to patients with heart attack.
If we can find out why high blood sugar is harmful to patients with heart attacks, and if we can show that treating these patients with more insulin than usual lessens these harmful effects, then we will be able to improve the way that these patients are treated. This could result in better survival and recovery for many heart attack patients.
All patients who volunteer for this study will get the best treatment available for heart attack- angioplasty, blood thinners, and the other heart medications that are usually given to these patients. Patients who have high blood sugar will be divided into two groups. One group will have their blood sugars measured and treated in the usual way. The other group will be treated with insulin run through an IV for 24 hours. After 24 hours, all patients will be treated in the usual way.
About one tablespoon of blood will be drawn from each patient at the time they sign up for the study and then 6, 12, 24, and 48 hours later. This blood will be used to test for inflammation and blood thickness.
The only ways in which patients who volunteer for this study will be treated differently from the standard of care are that they might receive more insulin than usual and they will have more blood drawn than usual. Giving extra insulin to these patients should not cause them harm, and may even help them. Since only about 5 tablespoons of extra blood will be drawn from each patient, this should not cause patients any harm.
Goals of this study
- To see what happens to blood inflammation and thickness in heart attack patients with normal blood sugar and compare this to patients with high blood sugar.
- To find out lowering patients' blood sugar levels more than we currently do will result in less blood inflammation and thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angioplasty with Insulin | Experimental | Drug: Intensive insulin therapyComing in with acute infarct and received angioplasty with intensive insulin therapy |
| Angioplasty w/o Insulin | No intervention | –Coming in with acute infarct and received angioplasty |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intensive insulin therapy | Drug | Angioplasty with Insulin |
Primary outcome
Troponin levels
Time frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)
2 secondary outcomes
CRP level
Time frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)
B-type natriuretic peptide levels.
Time frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)
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 16 Jun 2014.
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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.
Douglas C Morris, MD principal investigator
Emory Heart Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intensive insulin therapy in people with Acute Myocardial Infarction, run by Emory University at 2 sites 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?
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 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Troponin levels (time frame: Baseline, 24 hours, 48 hours, and 72 hours (post-procedure)). 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 16 Jun 2014.