Skip to main content
OpenTrials
Completed

NCT Number: NCT02164695

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 220060, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Unwillingness to participate
  • External electric shock for cardioversion within first 3 days
  • Cardiac surgery within first 3 days

Treatment and study plan

PPCI plus RIPC

Procedure

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 only

Procedure

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.

Primary outcomes

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

    Time frame: 6 months after index procedure

    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.

Secondary outcomes

  1. Enzymatic Infarct Size

    Time frame: 1 to 5 days after index procedure

    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.

  2. Resolution of ST-segment deviation

    Time frame: 1 to 5 days after index procedure

    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.

  3. Acute kidney injury

    Time frame: 1 to 3 days after index procedure

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Acronym: CAPRI

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 16, 2014
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.