Acute Myocardial InfarctionPhase 2/3NCT00248196
COOL MI II: Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
A Phase 2/3 study testing Reprieve Endovascular Temperature Therapy System in people with Acute Myocardial Infarction, run by Radiant Medical at 2 sites in United States.
Trial summary
Coronary heart disease is the single leading cause of death in the United States. In 2000, it was implicated in 681,000 deaths (1 in every 5 deaths). Myocardial infarction (MI) is the major cause of death in patients dying of coronary heart disease, with an estimated incidence of 1.1 million new and recurrent cases… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Reprieve Endovascular Temperature Therapy System
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Aug 2007
- Phase
- Phase 2/3
- 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
- The patient is greater than 18 years of age.
- The patient must have symptoms consistent with acute myocardial infarction (i.e. chest pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 30 minutes but less than 6 hours prior to presentation.
- Anterior wall MI with ST-segment elevation of ≥ 1 mm in two or more contiguous leads.
- The patient is eligible for percutaneous coronary intervention (PCI).
- The expected timing of the treatment pathway for the patient will allow for at least 30 minutes of cooling prior to PCI.
- The patient or patient legal guardian is willing to provide written, informed consent to participate in this clinical study.
Who cannot join
- The patient has had a previous myocardial infarction within one month.
- The patient is experiencing cardiogenic shock (systolic blood pressure [SBP] <80 mmHg and non-responsive to fluids, or SBP <100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump [IABP]).
- The patient has a known hypersensitivity to hypothermia, including a history of Raynaud's disease.
- The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia or sickle cell anemia, or will refuse blood transfusions.
- The patient has a height of <1.5 m (4 feet 11 inches).
Show all 13Show fewer
- The patient is known to be pregnant or is expected to become pregnant prior to the 1 month follow-up.
- The patient has a known hypersensitivity to buspirone hydrochloride or meperidine and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.
- Patient has a known history of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture, that in the opinion of the physician would be incompatible with meperidine administration.
- The patient has an inferior vena cava filter in place.
- The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities.
- The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
- The patient is currently enrolled in the COOL MI trial or in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with the COOL MI study endpoints. Note: For the purpose of this protocol, patients involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Coronary heart disease is the single leading cause of death in the United States. In 2000, it was implicated in 681,000 deaths (1 in every 5 deaths). Myocardial infarction (MI) is the major cause of death in patients dying of coronary heart disease, with an estimated incidence of 1.1 million new and recurrent cases per year. It is well established that reperfusion is the most successful treatment for salvaging myocardium during acute infarction. However, despite such treatment, a substantial number of patients still remain at risk of developing large infarcts, with reduced left ventricular function and increased mortality. Therefore, adjunctive therapies that are designed to reduce ischemic metabolism and cellular injury pending successful reperfusion, or to protect myocytes against the undesired effects of reperfusion ("reperfusion injury"), should be beneficial in limiting infarct size. Mild hypothermia is one such potential therapy. This study has been designed to evaluate whether the adjunctive use of mild hypothermia further reduces the extent of heart damage caused by a heart attack.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Reprieve Endovascular Temperature Therapy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reprieve Endovascular Temperature Therapy SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in infarct size (single photon emission computed tomography [SPECT])
Equivalent safety profile
Secondary outcomes (2)
Reduction in infarct size (creatinine kinase MB [CK-MB], ST- Segment Resolution)
Improvement in left ventricular ejection fraction (LVEF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2005 (estimated)
- Study startOct 2005
- Study completionAug 2007
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiant Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joseph P Carrozza, MD, Principal investigator, Beth Israel Deaconess Medical CenterSimon R Dixon, MBChB, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248196
- Sponsor's protocol ID
- 50-0045
- Status last verified
- Aug 2007
- First submitted
- 1 Nov 2005
- Last updated
- 21 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COOL MI II: Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00248196
- Acronym / sponsor ID
- 50-0045
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Radiant MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 3 Nov 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.
Coronary heart disease is the single leading cause of death in the United States. In 2000, it was implicated in 681,000 deaths (1 in every 5 deaths). Myocardial infarction (MI) is the major cause of death in patients dying of coronary heart disease, with an estimated incidence of 1.1 million new and recurrent cases per year. It is well established that reperfusion is the most successful treatment for salvaging myocardium during acute infarction. However, despite such treatment, a substantial number of patients still remain at risk of developing large infarcts, with reduced left ventricular function and increased mortality. Therefore, adjunctive therapies that are designed to reduce ischemic metabolism and cellular injury pending successful reperfusion, or to protect myocytes against the undesired effects of reperfusion ("reperfusion injury"), should be beneficial in limiting infarct size. Mild hypothermia is one such potential therapy. This study has been designed to evaluate whether the adjunctive use of mild hypothermia further reduces the extent of heart damage caused by a heart attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient is greater than 18 years of age.
- The patient must have symptoms consistent with acute myocardial infarction (i.e. chest pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 30 minutes but less than 6 hours prior to presentation.
- Anterior wall MI with ST-segment elevation of ≥ 1 mm in two or more contiguous leads.
- The patient is eligible for percutaneous coronary intervention (PCI).
- The expected timing of the treatment pathway for the patient will allow for at least 30 minutes of cooling prior to PCI.
Key exclusion criteria (13 listed)
- The patient has had a previous myocardial infarction within one month.
- The patient is experiencing cardiogenic shock (systolic blood pressure [SBP] <80 mmHg and non-responsive to fluids, or SBP <100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump [IABP]).
- The patient has a known hypersensitivity to hypothermia, including a history of Raynaud's disease.
- The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia or sickle cell anemia, or will refuse blood transfusions.
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 |
|---|---|---|
| Reprieve Endovascular Temperature Therapy System | Device | – |
Primary outcome
Reduction in infarct size (single photon emission computed tomography [SPECT])
Equivalent safety profile
2 secondary outcomes
Reduction in infarct size (creatinine kinase MB [CK-MB], ST- Segment Resolution)
Improvement in left ventricular ejection fraction (LVEF)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2008.
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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.
Joseph P Carrozza, MD principal investigator
Beth Israel Deaconess Medical Center
Simon R Dixon, MBChB principal investigator
Corewell Health East
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Reprieve Endovascular Temperature Therapy System in people with Acute Myocardial Infarction, run by Radiant Medical 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?
The sponsor lists 6 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: stopped early, as of the sponsor's last update on 21 Mar 2008. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Reduction in infarct size (single photon emission computed tomography [SPECT]). The study lists 2 primary outcomes in all. 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 21 Mar 2008.