NCT01067703

Brief Summary

The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2010

Typical duration for phase_3

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

September 1, 2014

Enrollment Period

3.4 years

First QC Date

February 10, 2010

Last Update Submit

December 1, 2015

Conditions

Myocardial InjuryMortality

Keywords

remote ischaemic preconditioning, cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure

    Time frame until hospital discharge

    In-hospital

Secondary Outcomes (5)

  • Occurence of any component of the composite outcome

    Postoperative hospital discharge, 3 months, 12 months

  • length of stay on the intensive care unit

    Postoperative during hospital stay

  • total hospital stay

    hospital discharge

  • new onset of atrial fibrillation

    In-hospital

  • Delirium

    Postoperative 24, 48, 72, 96 hrs

Study Arms (2)

RIPC

ACTIVE COMPARATOR
Procedure: Remote Ischemic Preconditioning

CONTROL

SHAM COMPARATOR
Procedure: Control/sham procedure (blood pressure cuff)

Interventions

Remote Ischemic PreconditioningPROCEDURE

RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200 mm Hg, whereas the pressure has to be at least 20 mm Hg greater than the systolic arterial pressure measured via the arterial line.

RIPC
Control/sham procedure (blood pressure cuff)PROCEDURE

Sham placement of the blood pressure cuff around a dummy arm inflated to a pressure of 200 mm Hg with four cycles of 5 min inflation and 5 min deflation.

CONTROL

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing heart surgery on cardiopulmonary bypass

You may not qualify if:

  • age \< 18
  • Emergency cases
  • left ventricular ejection fraction less than 30%
  • current atrial fibrillation
  • Inability to give informed consent
  • preoperative use of inotropics or mechanical assist device
  • severe liver, renal and pulmonary disease
  • recent myocardial infarction (within 7 days)
  • recent systemic infection or sepsis (within 7 days)
  • severe stroke (within 2 months)
  • peripheral vascular disease affecting upper limbs
  • previous serious psychiatric disorders (e.g. schizophrenia, dementia)
  • concomitant carotid endarterectomy
  • rare surgeries: cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, off-pump surgery, minimal-invasive operation without sternotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospital Aachen (RWTH)

Aachen, Germany

Location

University Hospital Charite

Berlin, Germany

Location

University Hospital Bonn

Bonn, Germany

Location

University Hospital Frankfurt/M

Frankfurt/M, Germany

Location

University Hospital Goettingen

Göttingen, Germany

Location

University Hospital Schleswig-Holstein

Kiel, Germany

Location

University Hospital of Schleswig-Holstein

Lübeck, Germany

Location

University Hospital Magdeburg

Magdeburg, Germany

Location

University Hospital Rostock

Rostock, Germany

Location

University Hospital Wuerzburg

Würzburg, Germany

Location

Related Publications (5)

  • Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Boning A, Niemann B, Roesner J, Kletzin F, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, Meyer-Treschan T, Kienbaum P, Heringlake M, Schon J, Sander M, Treskatsch S, Smul T, Wolwender E, Schilling T, Fuernau G, Hasenclever D, Zacharowski K; RIPHeart Study Collaborators. A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery. N Engl J Med. 2015 Oct 8;373(15):1397-407. doi: 10.1056/NEJMoa1413579. Epub 2015 Oct 5.

    PMID: 26436208RESULT

  • Meybohm P, Zacharowski K, Cremer J, Roesner J, Kletzin F, Schaelte G, Felzen M, Strouhal U, Reyher C, Heringlake M, Schon J, Brandes I, Bauer M, Knuefermann P, Wittmann M, Hachenberg T, Schilling T, Smul T, Maisch S, Sander M, Moormann T, Boening A, Weigand MA, Laufenberg R, Werner C, Winterhalter M, Treschan T, Stehr SN, Reinhart K, Hasenclever D, Brosteanu O, Bein B; RIP Heart-Study Investigator Group. Remote ischaemic preconditioning for heart surgery. The study design for a multi-center randomized double-blinded controlled clinical trial--the RIPHeart-Study. Eur Heart J. 2012 Jun;33(12):1423-6.

    PMID: 22880214RESULT

  • Westphal S, Stoppe C, Gruenewald M, Bein B, Renner J, Cremer J, Coburn M, Schaelte G, Boening A, Niemann B, Kletzin F, Roesner J, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Kortgen A, Stehr SN, Wittmann M, Baumgarten G, Struck R, Meyer-Treschan T, Kienbaum P, Heringlake M, Schoen J, Sander M, Treskatsch S, Smul T, Wolwender E, Schilling T, Degenhardt F, Franke A, Mucha S, Tittmann L, Kohlhaas M, Fuernau G, Brosteanu O, Hasenclever D, Zacharowski K, Meybohm P; RIPHeart-Study Collaborators. Genome-wide association study of myocardial infarction, atrial fibrillation, acute stroke, acute kidney injury and delirium after cardiac surgery - a sub-analysis of the RIPHeart-Study. BMC Cardiovasc Disord. 2019 Jan 24;19(1):26. doi: 10.1186/s12872-019-1002-x.

    PMID: 30678657DERIVED

  • Meybohm P, Kohlhaas M, Stoppe C, Gruenewald M, Renner J, Bein B, Albrecht M, Cremer J, Coburn M, Schaelte G, Boening A, Niemann B, Sander M, Roesner J, Kletzin F, Mutlak H, Westphal S, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, Meyer-Treschan T, Kienbaum P, Heringlake M, Schoen J, Treskatsch S, Smul T, Wolwender E, Schilling T, Fuernau G, Bogatsch H, Brosteanu O, Hasenclever D, Zacharowski K; RIPHeart (Remote Ischemic Preconditioning for Heart Surgery) Study Collaborators. RIPHeart (Remote Ischemic Preconditioning for Heart Surgery) Study: Myocardial Dysfunction, Postoperative Neurocognitive Dysfunction, and 1 Year Follow-Up. J Am Heart Assoc. 2018 Mar 26;7(7):e008077. doi: 10.1161/JAHA.117.008077.

    PMID: 29581218DERIVED

  • Candilio L, Malik A, Ariti C, Barnard M, Di Salvo C, Lawrence D, Hayward M, Yap J, Roberts N, Sheikh A, Kolvekar S, Hausenloy DJ, Yellon DM. Effect of remote ischaemic preconditioning on clinical outcomes in patients undergoing cardiac bypass surgery: a randomised controlled clinical trial. Heart. 2015 Feb;101(3):185-92. doi: 10.1136/heartjnl-2014-306178. Epub 2014 Sep 24.

    PMID: 25252696DERIVED

Study Officials

  • Patrick Meybohm, MD

    University Hospital Frankfurt/ University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

  • Berthold Bein, MD, DESA

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

  • Jochen Cremer, MD

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

  • Kai Zacharowski, MD, PhD

    University Hospital Frankfurt am Main

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Patrick Meybohm

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 11, 2010

Study Start

December 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2015

Last Updated

December 3, 2015

Record last verified: 2014-09

Locations

DE(10)