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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002-144 |
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| Name | Class |
|---|---|
| University College, London | OTHER |
| Queen Mary University of London | OTHER |
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Study hypothesis :
The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.
Aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracoronary | Experimental | Patients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route |
|
| Placebo | Placebo Comparator | Placebo infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone marrow derived progenitor cells or placebo infusion | Other | Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal change in left ventricular function (ejection fraction) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size | 3 months | |
| Longitudinal change in left ventricular function as measured by LV angiography | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Mathur, FRCP FESC Ph | Barts and the London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshopitalet, Unversity of Copenhagen | Copenhagen | Denmark | ||||
| Centre Hospitalier Universitaire Vaudois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26405233 | Derived | Choudry F, Hamshere S, Saunders N, Veerapen J, Bavnbek K, Knight C, Pellerin D, Locca D, Westwood M, Rakhit R, Crake T, Kastrup J, Parmar M, Agrawal S, Jones D, Martin J, Mathur A. A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trialdagger. Eur Heart J. 2016 Jan 14;37(3):256-63. doi: 10.1093/eurheartj/ehv493. Epub 2015 Sep 23. | |
| 24549163 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D056988 | Anterior Wall Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Placebo infusion | Other | Placebo infusion |
|
| Longitudinal change in left ventricular function assessed by echocardiography. | 6 months |
| Change in left ventricular end systolic volume and change in infarct size. | 12 months |
| Longitudinal change in left ventricular function assessed by echocardiography. | 12 months |
| MACE | 12 months |
| Change in Quality of life | 6 and 12 months |
| Lausanne |
| Switzerland |
| London Chest Hospital, Barts and The London NHS Trust | Bethnal Green | London | E2 9JX | United Kingdom |
| The Heart Hosptial, UCLH Foundation Trust | London | United Kingdom |
| The Royal Free Hospital, Royal Free London Foundation Trust | London | United Kingdom |
| Derived |
| Hamshere S, Choudhury T, Jones DA, Locca D, Mills P, Rothman M, Knight C, Parmar M, Agrawal S, Martin J, Mathur A. A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction (REGENERATE-AMI). BMJ Open. 2014 Feb 18;4(2):e004258. doi: 10.1136/bmjopen-2013-004258. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |