Ischemic Conditioning in STEMI Patients

NCT03097419 | Completed DMC

• 1 other identifier: 2012P000095
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of the study are to 1) study alterations in the metabolomic profile of patients exposed to post-ischemic conditions and 2) study alterations in myocardial infarction size of patients exposed to post-ischemic conditioning.

Conditions

Cardiac Arrest

Keywords

non-ST segment elevation myocardial infarction; myocardial infarction; remote ischemic conditioning; ischemic conditioning; sphygmomanometer; metabolomics

Outcome Measures

Primary Outcomes (1)

• Changes in the Metabolomic Profile

  The change in metabolic profiles as compared to a subject's baseline readout will be analyzed using both, an "untargeted" and a "targeted" approach. A comparison of the these changes will be made between the interventional and control groups.

  Time: 0 minutes (baseline), 60 minutes, 2 hours, 3 hours, 24 hours, and 72 hrs.

Study Arms (2)

Intervention

EXPERIMENTAL

Remote post-ischemic conditioning

Procedure: Remote post-ischemic conditioning

Control

NO INTERVENTION

Standard medical care by the primary treatment team.

Interventions

Remote post-ischemic conditioning PROCEDURE

A manual sphygmomanometer will be inflated over the brachial artery of the participants' arm that does not have an intravenous catheter actively infusing medications. If both arms are in use, then the participant's non-dominant arm will be used. * The sphygmomanometer will be inflated to a pressure at least 20 mmHg greater than the participants' last recorded systolic blood pressure. * The sphygmomanometer will be inflated for 5 minutes then rapidly deflated for 5 minutes, thereby concluding one iteration. * Five (5) total iterations constitute the treatment. * The left arm will be preferentially used instead of the right arm, unless the left arm is receiving medication administration.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient 18 ≥ years old in the BIDMC ED
• Clinical suspicion of myocardial infarction
• ECG without pathognomonic ST-segment elevation
• At least one positive troponin-T (\>0.10)

You may not qualify if:

• Inability to consent to enrollment
• Concurrent diagnosis of an emergent condition that may be antecedent to the NSTEMI
• Presentation to the ED greater than 24 hours after onset of NSTEMI symptoms
• Patients with a history of mastectomy or upper extremity arteriovenous fistula.
• Patients with active medication administration in both arms will be excluded from the study.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (13)

• Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.

  PMID: 20189026 BACKGROUND

• Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available.

  PMID: 17194875 BACKGROUND

• Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007 Aug 14;50(7):e1-e157. doi: 10.1016/j.jacc.2007.02.013. No abstract available.

  PMID: 17692738 BACKGROUND

• Walsh M, Whitlock R, Garg AX, Legare JF, Duncan AE, Zimmerman R, Miller S, Fremes S, Kieser T, Karthikeyan G, Chan M, Ho A, Nasr V, Vincent J, Ali I, Lavi R, Sessler DI, Kramer R, Gardner J, Syed S, VanHelder T, Guyatt G, Rao-Melacini P, Thabane L, Devereaux PJ; Remote IMPACT Investigators. Effects of remote ischemic preconditioning in high-risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial. CMAJ. 2016 Mar 15;188(5):329-336. doi: 10.1503/cmaj.150632. Epub 2015 Dec 14.

  PMID: 26668200 BACKGROUND

• Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.

  PMID: 3769170 BACKGROUND

• Piot C, Croisille P, Staat P, Thibault H, Rioufol G, Mewton N, Elbelghiti R, Cung TT, Bonnefoy E, Angoulvant D, Macia C, Raczka F, Sportouch C, Gahide G, Finet G, Andre-Fouet X, Revel D, Kirkorian G, Monassier JP, Derumeaux G, Ovize M. Effect of cyclosporine on reperfusion injury in acute myocardial infarction. N Engl J Med. 2008 Jul 31;359(5):473-81. doi: 10.1056/NEJMoa071142.

  PMID: 18669426 BACKGROUND

• Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.

  PMID: 16186417 BACKGROUND

• Vinten-Johansen J. Postconditioning: a mechanical maneuver that triggers biological and molecular cardioprotective responses to reperfusion. Heart Fail Rev. 2007 Dec;12(3-4):235-44. doi: 10.1007/s10741-007-9024-3.

  PMID: 17520362 BACKGROUND

• Zhou Y, Fathali N, Lekic T, Ostrowski RP, Chen C, Martin RD, Tang J, Zhang JH. Remote limb ischemic postconditioning protects against neonatal hypoxic-ischemic brain injury in rat pups by the opioid receptor/Akt pathway. Stroke. 2011 Feb;42(2):439-44. doi: 10.1161/STROKEAHA.110.592162. Epub 2010 Dec 23.

  PMID: 21183744 BACKGROUND

• Hausenloy DJ. Signalling pathways in ischaemic postconditioning. Thromb Haemost. 2009 Apr;101(4):626-34.

  PMID: 19350104 BACKGROUND

• Mamas M, Dunn WB, Neyses L, Goodacre R. The role of metabolites and metabolomics in clinically applicable biomarkers of disease. Arch Toxicol. 2011 Jan;85(1):5-17. doi: 10.1007/s00204-010-0609-6. Epub 2010 Oct 16.

  PMID: 20953584 BACKGROUND

• Montalescot G, Cayla G, Collet JP, Elhadad S, Beygui F, Le Breton H, Choussat R, Leclercq F, Silvain J, Duclos F, Aout M, Dubois-Rande JL, Barthelemy O, Ducrocq G, Bellemain-Appaix A, Payot L, Steg PG, Henry P, Spaulding C, Vicaut E; ABOARD Investigators. Immediate vs delayed intervention for acute coronary syndromes: a randomized clinical trial. JAMA. 2009 Sep 2;302(9):947-54. doi: 10.1001/jama.2009.1267.

  PMID: 19724041 BACKGROUND

• Alcalai R, Planer D, Culhaoglu A, Osman A, Pollak A, Lotan C. Acute coronary syndrome vs nonspecific troponin elevation: clinical predictors and survival analysis. Arch Intern Med. 2007 Feb 12;167(3):276-81. doi: 10.1001/archinte.167.3.276.

  PMID: 17296884 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nathan Shapiro, MD MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Model Details: We will perform a prospective, randomized-controlled study of 300 patients presenting to the BIDMC ED with a suspected non-ST segment elevation myocardial infarction. After obtaining consent, the patients will be assigned to either the intervention or standard of care group via a computerized block 1:1 randomization process.

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: March 31, 2017
• Study Start: November 28, 2012
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (1)