跳至主要内容
临床试验/NCT01898546
NCT01898546已完成不适用

Effect of Ischemic Postconditioning on Microvascular Obstruction in Reperfused Myocardial Infarction. Results of a Randomized Study in Patients

Fundación para la Investigación del Hospital Clínico de Valencia2 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
243
试验地点
2
主要终点
Microvascular obstruction

研究概览

简要总结

Objectives. We will evaluate the effect of ischemic postconditioning (PCON) on microvascular obstruction (MVO) in patients with a first ST-segment elevation myocardial infarction (STEMI) treated with primary angioplasty.

Background. PCON appears as a potentially beneficial tool in STEMI. Its impact on MVO is unknown.

Methods. In a multicenter study, 132 patients with a first STEMI will be randomized to undergo primary angioplasty followed by PCON or primary angioplasty alone (non-PCON). MVO and infarct size (IS) will be quantified (% of left ventricular mass) in a core laboratory analyzing late enhancement cardiovascular magnetic resonance imaging.

详细描述

INTRODUCTION

In ST-segment elevation myocardial infarction (STEMI) timely coronary reperfusion is the primary therapeutic goal to improve patients' outcome and to reduce left ventricular (LV) infarct size (IS). Unfortunately, despite successful reperfusion of the epicardial blood flow an impairment of microvascular perfusion persists in a significant number of patients, a phenomenon referred to as microvascular obstruction (MVO). This is a multifactorial process caused, among other factors, by microembolization, vasospasm and cells plugging. Cell reperfusion injury related to inflammation as well as to mitochondrial damage provoked by a rapid normalization of the acidotic myocardial environment do play a key role in the pathophysiology of MVO. In recent years MVO has been demonstrated to be a powerful and independent predictor of adverse outcome and larger IS. Cardiovascular magnetic resonance imaging (CMR) has become the state of the art technique for an early non-invasive comprehensive assessment of the structural consequences of STEMI, this including MVO.

Availability of inexpensive and easy-to-implement therapies that could solidly reduce MVO and subsequently optimize the beneficial effects of prompt primary percutaneous intervention would be of utmost importance. In recent years ischemic postconditioning (PCON) has appeared as a promising option. It permits a progressive, rather than brisk, restoration of blood flow to the jeopardized myocardium by means of consecutive cycles of inflation and deflation of the angioplasty balloon used to open the acute coronary occlusion. Previous experimental evidence and preliminary clinical data suggest that this simple strategy exerts, in comparison with the traditional rapid reperfusion using single balloon inflations, a number of protective myocardial effects.

During the last two years the effect of PCON on CMR-derived infarct size in STEMI patients has been evaluated but the results have been controversial. In routine practice, the time window to achieve any additional reduction in IS beyond that derived from timely coronary reperfusion is extremely tight. To the contrary, MVO owing to its pathophysiology and more progressive time course, seems a more suitable and realistic objective to explore the impact of this complementary therapy. Nevertheless the effect of PCON on MVO in STEMI is unknown so far.

In the present study we aim to analyse the effect of PCON on CMR-derived MVO in a randomized series of patients with a first STEMI treated with primary angioplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of age ≥ 18 years admitted to two university hospitals for a first STEMI within the first 12 h of chest pain onset, with ST-segment elevation of >0.1 mV in at least 2 contiguous leads and for whom the clinical decision to treat with percutaneous coronary intervention is made.

排除标准

  • Documented history of previous infarction
  • Primary percutaneous revascularization not attempted
  • Severe clinical or hemodynamic deterioration
  • Left main stem disease
  • Thrombolysis In Myocardial Infarction (TIMI) 2-3
  • Rentrop collateral flow grade ≥1 upon patient arrival
  • Death, re-infarction, cardiac surgery or severe clinical deterioration before CMR study
  • Patients who denied participation in the registry
  • Any contraindications to CMR

研究组 & 干预措施

Primary angioplasty and postconditioning

Experimental

Primary angioplasty followed by postconditioning

干预措施: Primary angioplasty (Procedure)

Primary angioplasty and postconditioning

Experimental

Primary angioplasty followed by postconditioning

干预措施: Postconditioning (Procedure)

Primary angioplasty

Active Comparator

Primary angioplasty alone

干预措施: Primary angioplasty (Procedure)

结局指标

主要结局

Microvascular obstruction

时间窗: 1 week

Microvascular obstruction will be visually defined as a lack of contrast uptake in the core of tissue showing late gadolinium enhancement; the extent of microvascular obstruction will be manually defined and expressed as percentage of LV mass

次要结局

  • Infarct size(1 week)

研究者

发起方
Fundación para la Investigación del Hospital Clínico de Valencia
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验