NCT01956708

Brief Summary

Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective CABG surgery. The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify the pathways which transfer the cardioprotective signal from the ischemic/reperfused extremity to the heart in humans undergoing surgical coronary revascularization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
392

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

6.6 years

First QC Date

September 27, 2013

Last Update Submit

October 8, 2021

Conditions

CABG

Outcome Measures

Primary Outcomes (1)

  • Myocardial protection

    Cumulative postoperative troponin T release

    72 h, postoperatively

Secondary Outcomes (5)

  • All-cause mortality

    30 days and 1 year after CABG surgery and after complete follow-up

  • MACCE

    30 days and 1 year after CABG surgery after complete follow-up

  • renal function

    72 h, postoperatively

  • Cardioprotective factors released into circulating blood

    before skin incision versus 1-72 h after RIPC

  • Myocardial function in vitro

    after RIPC

Study Arms (2)

Remote ischemic preconditioning

ACTIVE COMPARATOR

Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG): after induction of anesthesia and before surgery: 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200mmHg and 5 minutes of reperfusion Anesthesia is with isoflurane (0.7-0.8% end-tidal) +sufentanil

Procedure: RIPC

Placebo

PLACEBO COMPARATOR

No Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG): after induction of anesthesia and before surgery: the cuff is left uninflated

Procedure: RIPC

Interventions

RIPCPROCEDURE

3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion

Also known as: RIPC: Remote ischemic preconditioning
PlaceboRemote ischemic preconditioning

Eligibility Criteria

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

You may qualify if:

  • Consecutive patients \> 18 years after written informed consent
  • elective, isolated CABG surgery with and without valvuloplastic surgery
  • two-stage cannulation, cardiopulmonary bypass
  • antegrade Bretschneider cardioplegia
  • mild hypothermia (32°C)
  • preoperative standard medication (statins, betablocker, aspirin)
  • standard anesthesia (see above)
  • intraoperative standard protocol (full heparinization with ACT, aprotinin, protamin)
  • postoperative standard protocol (500 mg aspirin after 2 h, low-dose heparin after 4 h)

You may not qualify if:

  • preoperative
  • prior percutaneous coronary intervention (PCI) within 6 weeks
  • any preoperative troponin T elevation
  • renal insufficiency (creatinine \>200 µmol/l)
  • reoperation
  • emergency surgery
  • acute coronary syndrome (unstable angina, STEMI, NSTEMI) within 4 weeks
  • dual anti-platelet therapy (clopidogrel+aspirin)
  • intraoperative
  • harvesting of a. radialis
  • coronary thrombendarterectomy
  • complications (bypass-low flow/ -occlusion)
  • antithrombotic therapy (intraoperative clopidogrel + aspirin)
  • retrograde cardioplegia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen

Essen, 4130, Germany

Location

Study Officials

  • Markus Kamler, MD

    Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen, Essen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Markus Kamler

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

April 20, 2020

Study Completion

April 20, 2020

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations

DE(1)