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| Name | Class |
|---|---|
| University Hospitals, Leicester | OTHER |
| Freemasons' Medical Research Funding | UNKNOWN |
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Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the peri/immediate post infarct period. However little is known as to the effect of repeated remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial, the investigators intend to carry out daily remote ischaemic conditioning in post MI patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic resonance imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI |
|
| Sham arm | Sham Comparator | Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm | Procedure | Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in LVEF from baseline to 4 months as assessed by cMRI | Mean change in LVEF from baseline to 4 months as assessed by cMRI | Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Primary outcome measure assessed at baseline and 4 months post MI. |
| Measure | Description | Time Frame |
|---|---|---|
| Final infarct size at 4 months as assessed by cMRI | Final infarct size at 4 months as assessed by cMRI | Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI. |
| Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilesh Samani, FRCP, MD, MBChB, BSc | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univesrity of Leicester, Department of Cardiovascular Science | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35460434 | Derived | Arnold JR, P Vanezis A, Rodrigo GC, Lai FY, Kanagala P, Nazir S, Khan JN, Ng L, Chitkara K, Coghlan JG, Hetherington S, Samani NJ, McCann GP. Effects of late, repetitive remote ischaemic conditioning on myocardial strain in patients with acute myocardial infarction. Basic Res Cardiol. 2022 Apr 23;117(1):23. doi: 10.1007/s00395-022-00926-7. | |
| 29748420 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009203 | Myocardial Infarction |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
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|
| Sham conditioning | Procedure | Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury |
|
Mean blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) at baseline and 4 months |
| Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at baseline and 4 months post MI. |
| Mean KCCQ score at 4 months | Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months | Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI. |
| Vanezis AP, Arnold JR, Rodrigo G, Lai FY, Debiec R, Nazir S, Khan JN, Ng LL, Chitkara K, Coghlan JG, Hetherington SL, McCann GP, Samani NJ. Daily remote ischaemic conditioning following acute myocardial infarction: a randomised controlled trial. Heart. 2018 Dec;104(23):1955-1962. doi: 10.1136/heartjnl-2018-313091. Epub 2018 May 10. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011183 | Postoperative Complications |