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ST-segment Elevation Myocardial InfarctionCAPRINCT02164695

Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction

A study testing PPCI plus RIPC and PPCI only in people with ST-segment Elevation Myocardial Infarction, run by Yonsei University at 1 site in South Korea.

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

To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (PPCI) within 12 hours of symptoms onset. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
PPCI plus RIPC and PPCI only
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
1 siteSouth Korea
Study dates
31 Jan 2015to 31 Jan 2018
Phase
Interventional
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >19 years
  • Presenting within 12 hours of symptom onset
  • >20 min of chest pain
  • ST-elevation myocardial infarction defined as ST-segment elevation (>0.1 mV) in at least 2 contiguous precordial leads

Who cannot join

  • Previous myocardial infarction
  • Presence of chronic total occlusion
  • Evidence of retrograde filling by collaterals at coronary angiography (Rentrop 2 or 3 collateral flow)
  • Severe multi-vessel coronary artery disease to require further interventions before follow-up CMR
  • Cardiac arrest before randomization
  • Arrhythmias requiring external electric shock before randomization
Show all 9Show fewer
  • Unwillingness to participate
  • External electric shock for cardioversion within first 3 days
  • Cardiac surgery within first 3 days

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 220060

Other trials in South Korea

About this study

Official title: Cardioprotective Effects of Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (PPCI) within 12 hours of symptoms onset.

  • Control group: PPCI only
  • Study group: PPCI + RIPC

Primary endpoint: Infarct size measured by contrast-enhanced cardiac magnetic resonance (CMR) at 6 months after the index procedure

Read the detailed description

ST-elevation myocardial infarction (STEMI) is a leading cause of mortality and morbidity. Early myocardial reperfusion with either of thrombolytic therapy or primary percutaneous coronary intervention (PPCI) is the most effective strategy for reducing the size of a myocardial infarct and improving the clinical outcome. Although this process can restore blood flow to the ischemic myocardium, it can induce injury. This phenomenon termed myocardial reperfusion injury can paradoxically reduce the beneficial effects of myocardial reperfusion. The pre-clinical study in animal models of acute myocardial infarction suggests that lethal reperfusion injury accounts for up to 50% of the final size of a myocardial infarct.

Remote ischemic conditioning uses brief ischemia and reperfusion of a distant organ to protect the myocardium. In animal study, remote ischemic postconditioning seems to be more effective than local postconditioning in experimental myocardial infarction.Bøtker et al. has reported remote ischemic preconditioning before hospital admission increase myocardial salvage in patients with acute myocardial infarction.

The objective of this study is to evaluate whether remote ischemic per-conditioning (RIPC) can reduce late infarct size in patients with STEMI treated with PPCI within 12 hours of symptoms onset. To test this hypothesis, we will randomize patients into PPCI + RIPC or PPCI alone. We will evaluate marker of reperfusion injury using contrast cardiac magnetic resonance image.

Being tested
PPCI plus RIPC, PPCI only
Keywords
ST-segment elevation myocardial infarction, Remote ischemic perconditioning, Primary percutaneous coronary intervention, Cardiac magnetic resonance
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

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

  • PPCI plus RIPCProcedure or surgery

    All patients will be prepared with an upper-arm blood pressure cuff before arterial puncture (contralateral in case of radial access). In patients allocated into PPCI plus RIPC group, the protocol will be started immediately after cuff preparation. Upper-arm will be exposed to 4 cycles of ischemia/reperfusion, each obtained by 5 min cuff inflation at 200mmHg, followed by 5 min complete deflation.

  • PPCI onlyProcedure or surgery

    All patients randomized to PPCI only arm, the blood pressure cuff will be applied to the arm or the calf but will not be inflated.

Study groups in NCT02164695
Study groupRoleWhat they receive
PPCI plus RIPCActive comparatorThe patients randomized to PPCI plus RIPC group will receive RIPC during PPCI.
Receives: Procedure: PPCI plus RIPC
PPCI onlySham comparatorThe patients randomized to PPCI only group will receive PPCI only but the sham procedure of RIPC.
Receives: Procedure: PPCI only

What is being measured

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

  1. Infarct size measured by contrast-enhanced cardiac magnetic resonance

    Infarct size will be assessed on late-contrast images (≈10 min after gadolinium administration) by manually tracing the hyperintense area in each short-axis slice.

    Measured: 6 months after index procedure

Secondary outcomes (3)

  1. Enzymatic Infarct Size

    Enzymatic infarct size will be assessed by the area under the curve of creatine kinase-myocardial band (CK-MB) and troponin I (TnI) release. Blood samples will be collected before PCI and every day after index PPCI. Area under the curve of CK-MB and troponin I release will be expressed in arbitrary units and calculated with the trapezoidal method.

    Measured: 1 to 5 days after index procedure

  2. Resolution of ST-segment deviation

    ST-segment deviation score will be measured in 12-lead electrocardiograms, calculated as the sum (in millimeters) of ST-segment deviation (elevation or depression) at 80 ms after the J-point in all 12 leads. ST-segment deviation score will be measured at presentation and 30 min after PCI, by 2 physicians blinded as to the patients' data, and the mean value of the 2 assessments will be used. ST-segment resolution will be calculated as a percentage: ratio of the reduction in ST-segment deviation score from presentation to half an hour after PCI over the ST-segment deviation score at presentation × 100% (i.e., [(ST-segment deviation at presentation - ST-segment deviation post-PCI)/ST-segment deviation at presentation] × 100%). Full ST-segment resolution will be defined as 80% or more reduction of ST-segment deviation score.

    Measured: 1 to 5 days after index procedure

  3. Acute kidney injury

    Acute kidney injury will be defined as an absolute increase in serum creatinine of ≥0.5 mg/dl or a relative increase of ≥25% compared with baseline within 96 h after PCI (the maximal measured concentration of serum creatinine during these 96 h will be used). Relative reduction in estimated glomerular filtration rate (eGFR), calculated with the Modification of Diet in Renal Disease formula, within 96 h after PCI will be assessed.

    Measured: 1 to 3 days after index procedure

Timeline

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

  1. First posted16 Jun 2014 (estimated)
  2. Study start31 Jan 2015
  3. Primary completion31 Jul 2017
  4. Study completion31 Jan 2018

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
* Control group: PPCI only * Study group: PPCI + RIPC
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02164695
Sponsor's protocol ID
CR314003
Acronym
CAPRI
Status last verified
Nov 2021
First submitted
12 Jun 2014
Last updated
24 Nov 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing PPCI plus RIPC and PPCI only in people with ST-segment Elevation Myocardial Infarction, run by Yonsei University at 1 site in South Korea.

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 4 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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.

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?

Infarct size measured by contrast-enhanced cardiac magnetic resonance (time frame: 6 months after index procedure). 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 NCT02164695.

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 24 Nov 2021.

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