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Myocardial InjuryPhase 3NCT01067703

Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

A Phase 3 study testing Remote Ischemic Preconditioning in people with Myocardial Injury and Mortality, run by University Hospital Schleswig-Holstein at 10 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Myocardial Injury, Mortality
What is being tested?
Remote Ischemic Preconditioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,400 participants
Where
10 sitesGermany
Study dates
Dec 2010to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients undergoing heart surgery on cardiopulmonary bypass

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • University Hospital Aachen (RWTH)

    Aachen

  • University Hospital Charite

    Berlin

  • University Hospital Bonn

    Bonn

  • University Hospital Frankfurt/M

    Frankfurt/M

  • University Hospital Goettingen

    Göttingen

  • University Hospital Schleswig-Holstein

    Kiel

  • University Hospital of Schleswig-Holstein

    Lübeck

  • University Hospital Magdeburg

    Magdeburg

  • University Hospital Rostock

    Rostock

  • University Hospital Wuerzburg

    Würzburg

Other trials in Germany

About this study

Official title: Remote Ischaemic Preconditioning for Heart Surgery

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.

Read the detailed description

Cardiac surgery with cardiopulmonary bypass is associated with a predictable incidence of myocardial, neurological and renal dysfunction. This significant morbidity and mortality is at least partly due to perioperative ischaemia. Remote ischaemic preconditioning (RIPC) is a novel, simple, non-invasive and inexpensive intervention by which ischaemia of non-vital tissue (skeletal muscles) protects remote organs (heart, brain and kidney) from a subsequent sustained episode of ischaemia. The investigators perform a multicenter randomized controlled study to evaluate that RIPC reduces teh severity of perioperative ischaemic injury in patients undergoing cardiac surgery, and results in about 1/3 risk reduction in the occurence of major adverse events.

Being tested
Remote Ischemic Preconditioning, Control/sham procedure (blood pressure cuff)
Keywords
remote ischaemic preconditioning, cardiac surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote Ischemic PreconditioningProcedure or surgery

    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.

  • Control/sham procedure (blood pressure cuff)Procedure or surgery

    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.

Study groups in NCT01067703
Study groupRoleWhat they receive
RIPCActive comparatorNot described
Receives: Procedure: Remote Ischemic Preconditioning
CONTROLSham comparatorNot described
Receives: Procedure: Control/sham procedure (blood pressure cuff)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Time frame until hospital discharge

    Measured: In-hospital

Secondary outcomes (5)

  1. Occurence of any component of the composite outcome

    Measured: Postoperative hospital discharge, 3 months, 12 months

  2. length of stay on the intensive care unit

    Measured: Postoperative during hospital stay

  3. total hospital stay

    Measured: hospital discharge

  4. new onset of atrial fibrillation

    Measured: In-hospital

  5. Delirium

    Measured: Postoperative 24, 48, 72, 96 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionMay 2014
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01067703
Sponsor's protocol ID
ME 3559/1-1
Status last verified
Sep 2014
First submitted
10 Feb 2010
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26436208

  • 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.

    PubMed 22880214

  • 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.

    PubMed 30678657

  • 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.

    PubMed 29581218

  • 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.

    PubMed 25252696

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remote Ischemic Preconditioning in people with Myocardial Injury and Mortality, run by University Hospital Schleswig-Holstein at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (time frame: In-hospital). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01067703, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.

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