Remote Ischemic Conditioning in ST-elevation Myocardial Infarction as Adjuvant to Primary Angioplasty

NCT02313961 | Completed

• 1 other identifier: HB-CARD-01
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the RIC-STEMI trial is to assess whether remote ischaemic conditioning (RIC) as an adjunctive therapy during primary percutaneous coronary intervention (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) can improve clinical outcomes as assessed by death from cardiac-cause or hospitalization for heart failure (HF) for a minimum follow-up period of 12 months.

Conditions

ST Elevation Myocardial Infarction

Keywords

ST elevation myocardial infarction; Reperfusion injury; Remote ischaemic conditioning

Outcome Measures

Primary Outcomes (1)

• Combined outcome of death from cardiac cause or hospitalization for HF on follow-up, including device implantation (implantable cardioverter defibrillator, cardiac resynchronization and left ventricular assist device).

  Minimum follow up of 12 months

Secondary Outcomes (4)

• MI size.

  Index hospitalization.

• Left ventricular function.

  Index hospitalization.

• Acute kidney injury.

  Index hospitalization.

• Major adverse cardiovascular events

  Minimum follow up of 12 months

Study Arms (2)

RIC patients

EXPERIMENTAL

Subjects submitted to remote ischaemic conditioning (RIC)

Other: Remote ischaemic conditioning

No RIC patients

NO INTERVENTION

Subjects not submitted to remote ischaemic conditioning (RIC)

Interventions

Remote ischaemic conditioning OTHER

Remote ischaemic conditioning is induced by 3 cycles of manual inflation of a blood pressure cuff placed on the left lower limb to 200 mmHg for 5 minutes and then deflation to 0 mmHg for another 5 minutes.

RIC patients

Eligibility Criteria

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

You may qualify if:

• STEMI defined as chest pain (or epigastric pain) for more than 30 minutes and either: (i) new ST elevation at the J point in two contiguous leads with the cut-off points of ≥0.2 mV in men or ≥0.15 mV in women in leads V2-V3 or ≥0.1 mV in all other leads, (ii) or new or presumed new left bundle branch block (LBBB)
• Symptom onset not more than 12 h before presentation
• Willingness and capability to provide informed consent

You may not qualify if:

• Cardiogenic shock as defined by systemic hypotension (systolic arterial pressure - SAP - below 90 mmHg) and evidence of tissue hypoperfusion
• Post-cardiac arrest status
• Need for mechanical ventilation
• Known peripheral artery disease or evidence of lower limb ischemia
• Recent myocardial infarction (within 30 days)

Sponsors & Collaborators

• Hospital de Braga: lead
• Universidade do Porto: collaborator

Study Sites (1)

Hospital of Braga

Braga, Minho, 4710-243, Portugal

Location

Related Publications (11)

• Mandelzweig L, Battler A, Boyko V, Bueno H, Danchin N, Filippatos G, Gitt A, Hasdai D, Hasin Y, Marrugat J, Van de Werf F, Wallentin L, Behar S; Euro Heart Survey Investigators. The second Euro Heart Survey on acute coronary syndromes: Characteristics, treatment, and outcome of patients with ACS in Europe and the Mediterranean Basin in 2004. Eur Heart J. 2006 Oct;27(19):2285-93. doi: 10.1093/eurheartj/ehl196. Epub 2006 Aug 14.

  PMID: 16908490 BACKGROUND

• Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.

  PMID: 17855673 BACKGROUND

• Frohlich GM, Meier P, White SK, Yellon DM, Hausenloy DJ. Myocardial reperfusion injury: looking beyond primary PCI. Eur Heart J. 2013 Jun;34(23):1714-22. doi: 10.1093/eurheartj/eht090. Epub 2013 Mar 27.

  PMID: 23536610 BACKGROUND

• Dirksen MT, Laarman GJ, Simoons ML, Duncker DJ. Reperfusion injury in humans: a review of clinical trials on reperfusion injury inhibitory strategies. Cardiovasc Res. 2007 Jun 1;74(3):343-55. doi: 10.1016/j.cardiores.2007.01.014. Epub 2007 Jan 23.

  PMID: 17306241 BACKGROUND

• Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.

  PMID: 16750696 BACKGROUND

• Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.

  PMID: 17707752 BACKGROUND

• Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.

  PMID: 19188504 BACKGROUND

• 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

• Rentoukas I, Giannopoulos G, Kaoukis A, Kossyvakis C, Raisakis K, Driva M, Panagopoulou V, Tsarouchas K, Vavetsi S, Pyrgakis V, Deftereos S. Cardioprotective role of remote ischemic periconditioning in primary percutaneous coronary intervention: enhancement by opioid action. JACC Cardiovasc Interv. 2010 Jan;3(1):49-55. doi: 10.1016/j.jcin.2009.10.015.

  PMID: 20129568 BACKGROUND

• Sloth AD, Schmidt MR, Munk K, Kharbanda RK, Redington AN, Schmidt M, Pedersen L, Sorensen HT, Botker HE; CONDI Investigators. Improved long-term clinical outcomes in patients with ST-elevation myocardial infarction undergoing remote ischaemic conditioning as an adjunct to primary percutaneous coronary intervention. Eur Heart J. 2014 Jan;35(3):168-75. doi: 10.1093/eurheartj/eht369. Epub 2013 Sep 12.

  PMID: 24031025 BACKGROUND

• Gaspar A, Pereira MA, Azevedo P, Lourenco A, Marques J, Leite-Moreira A. Remote ischemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI): study protocol for a randomized controlled trial. Trials. 2015 Sep 8;16:398. doi: 10.1186/s13063-015-0937-1.

  PMID: 26350480 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Reperfusion Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• António Gaspar, MD

  Hospital of Braga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: March 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

PT (1)