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Myocardial Reperfusion InjuryPhase 2/3RemPostConNCT00865722

Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)

A Phase 2/3 study testing Remote Postconditioning in people with Myocardial Reperfusion Injury and Myocardial Ischemia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Experimental studies suggest that remote limb ischaemic postconditioning (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia in healthy volunteers and in patients with stable… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Remote Postconditioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
2 sitesItaly
Study dates
Mar 2009to May 2012
Phase
Phase 2/3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 yrs AND Age =< 80 yrs
  • STEMI definition
  • Pain to door time < 6 hrs
  • Killip class 1 - 2 - 3
  • Initial TIMI flow 0 - 1 in the anterior descending artery
  • Signed informed consent

Who cannot join

  • Pregnancy
  • Cardiogenic shock
  • Initial TIMI flow 2 - 3 in the anterior descending artery
  • History of prior MI in the past 6 months
  • History of prior CABG
  • History of peripheral vascular disease III - IV grade
Show all 9Show fewer
  • History of abdominal Aortic Aneurysm > 5 cm
  • Severe coronaropathy that could condition further revascularization before the end of the study
  • Other relevant medical or surgical conditions that can influence prognosis at 4 months

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • ASL3 Genovese, Villa Scassi Hospitale

    Genoa, 16100

  • IRCCS Policlinico San Matteo

    Pavia, Italy, 27100

Other trials in Italy

About this study

Official title: Pilot Study to Test Feasibility, Safety, Molecular Mediators and Preliminary Efficacy of Remote Myocardial Postconditioning Provided With Extrinsic Cuff Compression of Lower Limb During Primary PCI

Background: Experimental studies suggest that remote limb ischaemic postconditioning (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia in healthy volunteers and in patients with stable coronary artery disease.

Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators of its effects.

Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in a single-blind fashion. All patients receive therapy according to the current international guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion. RemPostCon is started at the time of angioplasty in the infarct related artery. Primary endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac magnetic resonance (CMR) is performed early before discharge and 4 months after the event, if there are no contraindications.

Being tested
Remote Postconditioning
Keywords
Remote Postconditioning, Myocardial reperfusion Injury, Myocardial Infarction, Primary PCI
Medical subject headings
Myocardial Reperfusion Injury, Myocardial Ischemia, Myocardial Infarction

What participants receive

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

  • Remote PostconditioningProcedure or surgery

    Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'

Study groups in NCT00865722
Study groupRoleWhat they receive
RemotePostConditioningActive comparatorPatients will receive pPCI and treatments according to guidelines for STEMI PLUS extrinsic cuff compression to the lower limb for 5 ' followed by 5' reperfusion for three cycles (30' in total) starting with myocardial reperfusion
Receives: Procedure: Remote Postconditioning
ControlsSham comparatorpPCI and treatments according to guidelines for STEMI
Receives: Procedure: Remote Postconditioning

What is being measured

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

  1. Area Under the Curve of CK - MB release

    Measured: baseline to 72h since admission

Secondary outcomes (14)

  1. Area Under the Curve of CK release

    Measured: baselinte to 72h since admission

  2. TIMI Frame Count

    Measured: 30 minutes after first balloon inflation in infarct-related artery

  3. Time to balloon

    Measured: during pPCI

  4. Ejection Fraction MRI

    Measured: before discharge and after 4 months

  5. Myocardial Blush grading

    Measured: 30 minutes after first balloon inflation

  6. ST segment resolution

    Measured: 6h after balloon

  7. Troponin I peak

    Measured: 72h since admission

  8. Mortality rate

    Measured: 4 months since admission

  9. artero-venous differences in pO2, pCO2, pH, HCo3

    Measured: baseline and 30 minutes after first balloon inflation

  10. Major adverse cardiac events

    Measured: 4 months since admission

  11. artero-venous quantitative and qualitative differences in endothelial progenitors cells (subgroups)

    Measured: within 24 h since admission

  12. artero-venous Differences of Cytokines

    Measured: within 24h since admission

  13. Edema Volume T2 sequences MRI

    Measured: before discharge

  14. Delay enhancement volume MRI

    Measured: before discharge and after 4 months

Timeline

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

  1. First posted19 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMay 2012
  4. Study completionMay 2012

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00865722
Sponsor's protocol ID
RemPostConditioning
Acronym
RemPostCon
Status last verified
Aug 2012
First submitted
18 Mar 2009
Last updated
17 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • Crimi G, Pica S, Raineri C, Bramucci E, De Ferrari GM, Klersy C, Ferlini M, Marinoni B, Repetto A, Romeo M, Rosti V, Massa M, Raisaro A, Leonardi S, Rubartelli P, Oltrona Visconti L, Ferrario M. Remote ischemic post-conditioning of the lower limb during primary percutaneous coronary intervention safely reduces enzymatic infarct size in anterior myocardial infarction: a randomized controlled trial. JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63. doi: 10.1016/j.jcin.2013.05.011.

    PubMed 24156966

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Remote Postconditioning in people with Myocardial Reperfusion Injury and Myocardial Ischemia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.

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 6 inclusion and 9 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: finished, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area Under the Curve of CK - MB release (time frame: baseline to 72h since admission). 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 NCT00865722, which also lists 1 linked publication.

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 17 Aug 2012.

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