Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)
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ClinicalTrials.gov Identifier: NCT01067703 |
Recruitment Status :
Terminated
First Posted : February 11, 2010
Last Update Posted : December 3, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Injury Mortality | Procedure: Remote Ischemic Preconditioning Procedure: Control/sham procedure (blood pressure cuff) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Remote Ischaemic Preconditioning for Heart Surgery |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: RIPC |
Procedure: Remote Ischemic Preconditioning
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. |
Sham Comparator: CONTROL |
Procedure: Control/sham procedure (blood pressure cuff)
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. |
- Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure [ Time Frame: In-hospital ]Time frame until hospital discharge
- Occurence of any component of the composite outcome [ Time Frame: Postoperative hospital discharge, 3 months, 12 months ]
- length of stay on the intensive care unit [ Time Frame: Postoperative during hospital stay ]
- total hospital stay [ Time Frame: hospital discharge ]
- new onset of atrial fibrillation [ Time Frame: In-hospital ]
- Delirium [ Time Frame: Postoperative 24, 48, 72, 96 hrs ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients undergoing heart surgery on cardiopulmonary bypass
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067703
Germany | |
University Hospital Aachen (RWTH) | |
Aachen, Germany | |
University Hospital Charite | |
Berlin, Germany | |
University Hospital Bonn | |
Bonn, Germany | |
University Hospital Frankfurt/M | |
Frankfurt/M, Germany | |
University Hospital Goettingen | |
Goettingen, Germany | |
University Hospital Schleswig-Holstein | |
Kiel, Germany | |
University Hospital of Schleswig-Holstein | |
Luebeck, Germany | |
University Hospital Magdeburg | |
Magdeburg, Germany | |
University Hospital Rostock | |
Rostock, Germany | |
University Hospital Wuerzburg | |
Wuerzburg, Germany |
Principal Investigator: | 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Patrick Meybohm, Prof. Dr. Patrick Meybohm, University Hospital Schleswig-Holstein |
ClinicalTrials.gov Identifier: | NCT01067703 |
Other Study ID Numbers: |
ME 3559/1-1 |
First Posted: | February 11, 2010 Key Record Dates |
Last Update Posted: | December 3, 2015 |
Last Verified: | September 2014 |
remote ischaemic preconditioning, cardiac surgery |
Ischemia Pathologic Processes |