Myocardial Infarction Complicated With Cardiogenic ShockPhase 3NCT00846222
Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
A Phase 3 study testing Hypothermia in people with Myocardial Infarction Complicated With Cardiogenic Shock, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Myocardial Infarction Complicated With Cardiogenic Shock
- What is being tested?
- Hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Jul 2010
- Phase
- Phase 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent myocardial infarction: 24 hours of start pain
- Pump failure cardiogenic shock (defined as persistent hypotension, systolic BP < 90 mmHg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs
- Candidate for immediate percutaneous reperfusion
- Maximal care support: mechanical ventilation, intraaortic balloon contrapulsation
Who cannot join
- Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
- Pregnant women
- Absence of maximal support care
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock
- Being tested
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypothermiaProcedure or surgery
Mild therapeutic hypothermia, 33-34 celsius, for 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Mild theraputic hypothermia | Experimental | Not described Receives: Procedure: Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
Measured: 30 days
Secondary outcomes (1)
Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction Complicated With Cardiogenic ShockStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846222
- Sponsor's protocol ID
- 192/08
- Status last verified
- Feb 2009
- First submitted
- 16 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Dixon SR, Whitbourn RJ, Dae MW, Grube E, Sherman W, Schaer GL, Jenkins JS, Baim DS, Gibbons RJ, Kuntz RE, Popma JJ, Nguyen TT, O'Neill WW. Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction. J Am Coll Cardiol. 2002 Dec 4;40(11):1928-34. doi: 10.1016/s0735-1097(02)02567-6.
PubMed 12475451Hale SL, Dave RH, Kloner RA. Regional hypothermia reduces myocardial necrosis even when instituted after the onset of ischemia. Basic Res Cardiol. 1997 Oct;92(5):351-7. doi: 10.1007/BF00788947.
PubMed 9486356
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00846222
- Acronym / sponsor ID
- 192/08
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 18 Feb 2009 (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 evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild theraputic hypothermia | Experimental | Procedure: Hypothermia |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent myocardial infarction: 24 hours of start pain
- Pump failure cardiogenic shock (defined as persistent hypotension, systolic BP < 90 mmHg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs
- Candidate for immediate percutaneous reperfusion
- Maximal care support: mechanical ventilation, intraaortic balloon contrapulsation
Key exclusion criteria (3 listed)
- Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
- Pregnant women
- Absence of maximal support care
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 |
|---|---|---|
| HypothermiaMild therapeutic hypothermia, 33-34 celsius, for 12 hours | Procedure or surgery | Mild theraputic hypothermia |
Primary outcome
Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
Time frame: 30 days
1 secondary outcome
Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
- Background: PubMed 12475451Dixon SR, Whitbourn RJ, Dae MW, Grube E, Sherman W, Schaer GL, Jenkins JS, Baim DS, Gibbons RJ, Kuntz RE, Popma JJ, Nguyen TT, O'Neill WW. Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction. J Am Coll Cardiol. 2002 Dec 4;40(11):1928-34. doi: 10.1016/s0735-1097(02)02567-6.
- Background: PubMed 9486356Hale SL, Dave RH, Kloner RA. Regional hypothermia reduces myocardial necrosis even when instituted after the onset of ischemia. Basic Res Cardiol. 1997 Oct;92(5):351-7. doi: 10.1007/BF00788947.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypothermia in people with Myocardial Infarction Complicated With Cardiogenic Shock, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Feb 2009. 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 Israel. 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 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?
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?
Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00846222, which also lists 2 linked publications.
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 18 Feb 2009.