Acute Myocardial InfarctionNCT03015155
Therapeutic Effect of Local Hypothermia in Treatment of Acute Myocardial Infarction
A study testing Infusion of Cold Saline into Local Infarction Myocardium. in people with Acute Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Recent clinical studies have shown that systemic therapeutic hypothermia improving the outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have described the methods, mechanism and rationale… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Infusion of Cold Saline into Local Infarction Myocardium.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Dec 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present with an anterior or inferior STEMI with ST-segment elevation of 0.2 mV in >2 or more anatomically contiguous leads and a duration of symptoms of <6 hours are included.
- -
Who cannot join
- Participants with cardiac arrest, previous AMI, previous PCI or CABG, known congestive heart failure, end-stage kidney disease or hepatic failure, coagulopathy, pregnancy, or Killip class II through IV at presentation are excluded in this study.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Local Myocardial Hypothermia on Outcomes in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.
Recent clinical studies have shown that systemic therapeutic hypothermia improving the outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have described the methods, mechanism and rationale of therapeutic hypothermia, including local myocardial hypothermia. However, little is known of the local myocardial hypothermia having impact on prognosis of the patients with acute myocardial infarction. The aim of this study is to ascertain whether local myocardial hypothermia is effective in treatment of ischemia/reperfusion injury in patients with STEMI undergoing P-PCI.
Read the detailed description
Ethics and organization The study was designed in agreement with the Declaration of Nanjing, and the study protocol was approved by the local ethics committees. A written informed consent will be completed before inclusion. The trial was coordinated and monitored by the First Affiliated Hospital with Nanjing Medical University. An independent data and safety monitoring board, including of physicians independent of the trial sponsor and operational leadership, monitored the safety of the study.
Study population From March 2017 to March 2019, 300 patients from department of cardiology (the First Affiliated Hospital with Nanjing Medical University, Nanjing, China) will be enrolled in this prospective, randomized, end point-blinded study to evaluate the local hypothermia as an adjunct therapy in patients with acute myocardial infarction (AMI) eligible for primary percutaneous intervention (PPCI). Men and women ages 40 and 80 years presenting with anterior or non-anterior AMIs with ST-segment elevation>0.2 mV in 2 contiguous leads and a duration of symptoms<12h will be included. We will collect a second electrocardiogram in the catheterization laboratory before randomization to ensure persistent ST-segment elevation. We conduct the exclusive criterion, including patients with previous AMIs, previous PCI or coronary artery bypass grafting, congestive heart failure, end-stage kidney disease or hepatic failure, recent stroke, coagulopathy, pregnancy, cardiac arrest, or Killip class II to IV at presentation.
Protocol. The AMI patients will be randomized 1:1 to hypothermia or standard of care before coronary angiography. Using varying block sizes and stratification, we generate the randomization list by computer. A standard working guide-wire, Runthrough NS (Terumo Corporation, Japan), is advanced into the distal part of the target coronary artery after determining of the criminal vessel by using angiography. Compared to the standard PPCI after the balloon expansion, the aspirated catheter (Diver C.E. MAX, Invatec S.p.A, Italy) is firstly placed at the location of the distal occlusion lesion to achieve local myocardial hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated catheter, following the balloon expansion and the drug eluting stent implanting. Subsequently, the infusion catheter is tautologically placed at the location of the opened occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline (4℃, 2.5ml/min, 15min). Loading doses of 300 mg of aspirin, 180 mg ticagrelor and heparin (100u/kg) will be given to all patients before cardiac catheterization. Glycoprotein IIb/IIIa inhibitors, bivalirudin and sodium nitroprusside will be administered at the discretion of the treating physician.
Measurements To analyze the ventricular dimensions, myocardium at risk (MaR) and infarct size, using postprocessing software, patients will be allocated to undergo cardiac magnetic resonance examinations at the core laboratory (the First Affiliated Hospital with Nanjing Medical University, Nanjing, China).
Troponin T/I, myoglobin, and creatine kinase-MB will be sampled before randomization and at 12 and 24 h after catheterization. We define the peak values as the highest measured values within 24 h by calculating under area of the curve from the measurements. N-terminal pro-brain natriuretic peptide will be sampled and dynamic electrocardiogram be performed at 48h after admission.
Clinical endpoints. Clinical events will be collected using a clinical report form during the index hospital stay, at 30±10 days, and at 12 months. Furthermore, adverse event and serious adverse event reporting will be collected as clinical endpoints. The independent monitors supervise hospital charts for all patients. All primary events (death, re-infarction, target lesion revascularization, major bleeding and heart failure) will be assessed independently by a blinded clinical events committee.
Statistical analysis. Calculations and statistics will be performed by using the GraphPad Prism 5.0 software (GraphPad Software Inc, La Jolla, Calif). The Fisher exact test will be performed on categorical variables. Continuous variables will be tested using Mann-Whitney Utest with exact inference. Statistical significance will be conducted at P<0.05.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Infusion of Cold Saline into Local Infarction Myocardium.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of Cold Saline into Local Infarction Myocardium.Procedure or surgery
Infusion of Cold Saline into the Area of Ischemic Myocardium by Using Aspirated Catheter Before the Ischemia/reperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Experimental | Infusion of Cold Saline into Local Infarction Myocardium. A standard working guide-wire, Runthrough NS (Terumo, Japan), is advanced into the distal part of the target coronary artery by using angiography. Compared to the standard PPCI after the balloon expansion, the aspirated catheter (Diver C.E. MAX, Italy) is firstly placed at the location of the distal occlusion lesion to achieve local myocardial hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated catheter, following the balloon expansion and the drug eluting stent implanting. Subsequently, the infusion catheter is tautologically placed at the location of the opened occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline (4℃, 2.5ml/min, 15min). Receives: Procedure: Infusion of Cold Saline into Local Infarction Myocardium. |
| Standard treatment | No intervention | We place a standard working guide-wire, Runthrough NS (Terumo Corporation, Japan), crossover the criminal lesion of to the distal of the target coronary artery after angiography. Then the pre-dilated balloon is placed at the occluded lesion site to expand the criminal vessel without hypothermia intervention. The operation will be completed when the flow of target coronary artery achieves TIMI class 3 after the drug eluting stent implanting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct Size
Measured: The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startMar 2017
- Primary completionMar 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lian-Sheng Wang, MD, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015155
- Sponsor's protocol ID
- LS-81570363
- Status last verified
- Dec 2016
- First submitted
- 6 Jan 2017
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Erlinge D, Gotberg M, Noc M, Lang I, Holzer M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Koul S, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Klos B, Harnek J, Olivecrona GK. Therapeutic hypothermia for the treatment of acute myocardial infarction-combined analysis of the RAPID MI-ICE and the CHILL-MI trials. Ther Hypothermia Temp Manag. 2015 Jun;5(2):77-84. doi: 10.1089/ther.2015.0009. Epub 2015 May 18.
PubMed 25985169Villablanca PA, Rao G, Briceno DF, Lombardo M, Ramakrishna H, Bortnick A, Garcia M, Menegus M, Sims D, Makkiya M, Mookadam F. Therapeutic hypothermia in ST elevation myocardial infarction: a systematic review and meta-analysis of randomised control trials. Heart. 2016 May;102(9):712-9. doi: 10.1136/heartjnl-2015-308559. Epub 2016 Feb 10.
PubMed 26864673Kohlhauer M, Berdeaux A, Ghaleh B, Tissier R. Therapeutic hypothermia to protect the heart against acute myocardial infarction. Arch Cardiovasc Dis. 2016 Dec;109(12):716-722. doi: 10.1016/j.acvd.2016.05.005. Epub 2016 Sep 28.
PubMed 27692660Kim H, Lee J, Song W, Shin J, Oh D, Harrison K, Jakkula M, Wong SC, Hong MK. Feasibility and safety of regional myocardial hypothermia during myocardial ischemia and infarction in pigs. Coron Artery Dis. 2005 Mar;16(2):125-9. doi: 10.1097/00019501-200503000-00008.
PubMed 15735406Otake H, Shite J, Paredes OL, Shinke T, Yoshikawa R, Tanino Y, Watanabe S, Ozawa T, Matsumoto D, Ogasawara D, Yokoyama M. Catheter-based transcoronary myocardial hypothermia attenuates arrhythmia and myocardial necrosis in pigs with acute myocardial infarction. J Am Coll Cardiol. 2007 Jan 16;49(2):250-60. doi: 10.1016/j.jacc.2006.06.080. Epub 2006 Dec 29.
PubMed 17222738Otterspoor LC, Van't Veer M, van Nunen LX, Wijnbergen I, Tonino PA, Pijls NH. Safety and feasibility of local myocardial hypothermia. Catheter Cardiovasc Interv. 2016 Apr;87(5):877-83. doi: 10.1002/ccd.26139. Epub 2015 Aug 13.
PubMed 26269225Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.
PubMed 24509284Dixon 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 12475451
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Myocardial Hypothermia on Outcomes in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT03015155
- Acronym / sponsor ID
- LS-81570363
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2017
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Jan 2017 (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.
Recent clinical studies have shown that systemic therapeutic hypothermia improving the outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have described the methods, mechanism and rationale of therapeutic hypothermia, including local myocardial hypothermia. However, little is known of the local myocardial hypothermia having impact on prognosis of the patients with acute myocardial infarction. The aim of this study is to ascertain whether local myocardial hypothermia is effective in treatment of ischemia/reperfusion injury in patients with STEMI undergoing P-PCI.
Detailed description
Ethics and organization The study was designed in agreement with the Declaration of Nanjing, and the study protocol was approved by the local ethics committees. A written informed consent will be completed before inclusion. The trial was coordinated and monitored by the First Affiliated Hospital with Nanjing Medical University. An independent data and safety monitoring board, including of physicians independent of the trial sponsor and operational leadership, monitored the safety of the study.
Study population From March 2017 to March 2019, 300 patients from department of cardiology (the First Affiliated Hospital with Nanjing Medical University, Nanjing, China) will be enrolled in this prospective, randomized, end point-blinded study to evaluate the local hypothermia as an adjunct therapy in patients with acute myocardial infarction (AMI) eligible for primary percutaneous intervention (PPCI). Men and women ages 40 and 80 years presenting with anterior or non-anterior AMIs with ST-segment elevation>0.2 mV in 2 contiguous leads and a duration of symptoms<12h will be included. We will collect a second electrocardiogram in the catheterization laboratory before randomization to ensure persistent ST-segment elevation. We conduct the exclusive criterion, including patients with previous AMIs, previous PCI or coronary artery bypass grafting, congestive heart failure, end-stage kidney disease or hepatic failure, recent stroke, coagulopathy, pregnancy, cardiac arrest, or Killip class II to IV at presentation.
Protocol. The AMI patients will be randomized 1:1 to hypothermia or standard of care before coronary angiography. Using varying block sizes and stratification, we generate the randomization list by computer. A standard working guide-wire, Runthrough NS (Terumo Corporation, Japan), is advanced into the distal part of the target coronary artery after determining of the criminal vessel by using angiography. Compared to the standard PPCI after the balloon expansion, the aspirated catheter (Diver C.E. MAX, Invatec S.p.A, Italy) is firstly placed at the location of the distal occlusion lesion to achieve local myocardial hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated catheter, following the balloon expansion and the drug eluting stent implanting. Subsequently, the infusion catheter is tautologically placed at the location of the opened occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline (4℃, 2.5ml/min, 15min). Loading doses of 300 mg of aspirin, 180 mg ticagrelor and heparin (100u/kg) will be given to all patients before cardiac catheterization. Glycoprotein IIb/IIIa inhibitors, bivalirudin and sodium nitroprusside will be administered at the discretion of the treating physician.
Measurements To analyze the ventricular dimensions, myocardium at risk (MaR) and infarct size, using postprocessing software, patients will be allocated to undergo cardiac magnetic resonance examinations at the core laboratory (the First Affiliated Hospital with Nanjing Medical University, Nanjing, China).
Troponin T/I, myoglobin, and creatine kinase-MB will be sampled before randomization and at 12 and 24 h after catheterization. We define the peak values as the highest measured values within 24 h by calculating under area of the curve from the measurements. N-terminal pro-brain natriuretic peptide will be sampled and dynamic electrocardiogram be performed at 48h after admission.
Clinical endpoints. Clinical events will be collected using a clinical report form during the index hospital stay, at 30±10 days, and at 12 months. Furthermore, adverse event and serious adverse event reporting will be collected as clinical endpoints. The independent monitors supervise hospital charts for all patients. All primary events (death, re-infarction, target lesion revascularization, major bleeding and heart failure) will be assessed independently by a blinded clinical events committee.
Statistical analysis. Calculations and statistics will be performed by using the GraphPad Prism 5.0 software (GraphPad Software Inc, La Jolla, Calif). The Fisher exact test will be performed on categorical variables. Continuous variables will be tested using Mann-Whitney Utest with exact inference. Statistical significance will be conducted at P<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | Experimental | Procedure: Infusion of Cold Saline into Local Infarction Myocardium.Infusion of Cold Saline into Local Infarction Myocardium. A standard working guide-wire, Runthrough NS (Terumo, Japan), is advanced into the distal part of the target coronary artery by using angiography. Compared to the standard PPCI after the balloon expansion, the aspirated catheter (Diver C.E. MAX, Italy) is firstly placed at the location of the distal occlusion lesion to achieve local myocardial hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated catheter, following the balloon expansion and the drug eluting stent implanting. Subsequently, the infusion catheter is tautologically placed at the location of the opened occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline (4℃, 2.5ml/min, 15min). |
| Standard treatment | No intervention | –We place a standard working guide-wire, Runthrough NS (Terumo Corporation, Japan), crossover the criminal lesion of to the distal of the target coronary artery after angiography. Then the pre-dilated balloon is placed at the occluded lesion site to expand the criminal vessel without hypothermia intervention. The operation will be completed when the flow of target coronary artery achieves TIMI class 3 after the drug eluting stent implanting. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who present with an anterior or inferior STEMI with ST-segment elevation of 0.2 mV in >2 or more anatomically contiguous leads and a duration of symptoms of <6 hours are included.
- -
Key exclusion criteria (2 listed)
- Participants with cardiac arrest, previous AMI, previous PCI or CABG, known congestive heart failure, end-stage kidney disease or hepatic failure, coagulopathy, pregnancy, or Killip class II through IV at presentation are excluded in this study.
- -
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 |
|---|---|---|
| Infusion of Cold Saline into Local Infarction Myocardium.Infusion of Cold Saline into the Area of Ischemic Myocardium by Using Aspirated Catheter Before the Ischemia/reperfusion. | Procedure or surgery | Hypothermia |
Primary outcome
Infarct Size
Time frame: The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Background: PubMed 25985169Erlinge D, Gotberg M, Noc M, Lang I, Holzer M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Koul S, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Klos B, Harnek J, Olivecrona GK. Therapeutic hypothermia for the treatment of acute myocardial infarction-combined analysis of the RAPID MI-ICE and the CHILL-MI trials. Ther Hypothermia Temp Manag. 2015 Jun;5(2):77-84. doi: 10.1089/ther.2015.0009. Epub 2015 May 18.
- Background: PubMed 26864673Villablanca PA, Rao G, Briceno DF, Lombardo M, Ramakrishna H, Bortnick A, Garcia M, Menegus M, Sims D, Makkiya M, Mookadam F. Therapeutic hypothermia in ST elevation myocardial infarction: a systematic review and meta-analysis of randomised control trials. Heart. 2016 May;102(9):712-9. doi: 10.1136/heartjnl-2015-308559. Epub 2016 Feb 10.
- Background: PubMed 27692660Kohlhauer M, Berdeaux A, Ghaleh B, Tissier R. Therapeutic hypothermia to protect the heart against acute myocardial infarction. Arch Cardiovasc Dis. 2016 Dec;109(12):716-722. doi: 10.1016/j.acvd.2016.05.005. Epub 2016 Sep 28.
- Results publication: PubMed 15735406Kim H, Lee J, Song W, Shin J, Oh D, Harrison K, Jakkula M, Wong SC, Hong MK. Feasibility and safety of regional myocardial hypothermia during myocardial ischemia and infarction in pigs. Coron Artery Dis. 2005 Mar;16(2):125-9. doi: 10.1097/00019501-200503000-00008.
- Results publication: PubMed 17222738Otake H, Shite J, Paredes OL, Shinke T, Yoshikawa R, Tanino Y, Watanabe S, Ozawa T, Matsumoto D, Ogasawara D, Yokoyama M. Catheter-based transcoronary myocardial hypothermia attenuates arrhythmia and myocardial necrosis in pigs with acute myocardial infarction. J Am Coll Cardiol. 2007 Jan 16;49(2):250-60. doi: 10.1016/j.jacc.2006.06.080. Epub 2006 Dec 29.
- Results publication: PubMed 26269225Otterspoor LC, Van't Veer M, van Nunen LX, Wijnbergen I, Tonino PA, Pijls NH. Safety and feasibility of local myocardial hypothermia. Catheter Cardiovasc Interv. 2016 Apr;87(5):877-83. doi: 10.1002/ccd.26139. Epub 2015 Aug 13.
- Results publication: PubMed 24509284Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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.
Lian-Sheng Wang, MD, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Infusion of Cold Saline into Local Infarction Myocardium. in people with Acute Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University.
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 2 inclusion and 2 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lian-Sheng Wang, MD, PhD (0086-25-83724440, drlswang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct Size (time frame: The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7.). 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 NCT03015155, which also lists 8 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 9 Jan 2017.