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OpenTrials
Completed

NCT Number: NCT01158716

Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. The investigators hypothesized that a single remote ischemic preconditioning cycle would reduce peri-procedural troponin release.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athens Euroclinic

Athens, Attica, 11521, Greece

About this study

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases, which is a sensitive and specific marker of myocyte necrosis. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events and a worst prognosis, especially in those patients with the most marked elevation in troponin concentration.

Recently, 3 cycles of 5-minute ischemia followed by 5-minute reperfusion of the upper extremities were shown to reduce troponin release in elective PCI. However, this ischemic preconditioning (IPC) protocol requires 30 minutes and is of limited use in the context of PCI at the time of initial cardiac catheterization (ad hoc coronary intervention).

Since experimental evidence suggests that IPC is a graded than an "all-or-nothing" phenomenon, and even a short, single IPC cycle may have protective effects in the myocardium, the investigators hypothesized that patients undergoing ad hoc coronary intervention would have reduced peri-procedural troponin release if subjected to a single, remote IPC cycle, between diagnostic catheterization and coronary intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a significant stenosis as documented in coronary angiography eligible for PCI
  • Patients ≥ 18 of age and able to give informed consent

Exclusion criteria

  • Severe comorbidity (estimated life expectancy <6 months)
  • Use of nicorandil or glibenclamide
  • Elevated baseline cTnI before PCI
  • Renal disease as documented by serum creatinine before PCI
  • LVEF<35%

Treatment and study plan

Remote Ischemic Preconditioning

Other

Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)

Primary outcomes

  1. Delta Cardiac Troponin I (ΔcTnI)

    Time frame: 24 hours post PCI

    ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography

Secondary outcomes

  1. Chest Pain During Coronary Balloon Occlusion

    Time frame: During coronary balloon occlusion

    Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced)

  2. ECG Evidence of Ischemia During Coronary Balloon Occlusion

    Time frame: During coronary balloon occlusion

    ST-segment deviation as monitored during coronary balloon occlusion

Sponsors and collaborators

Lead sponsor

Cardiovascular Research Society, Greece

Other

Registry information

Official study title

Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2010
Registry last updated
Apr 9, 2014

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.

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