MVO 09/150/28

• Research type

  Research Study

• Full title

  Randomized Controlled Trial Comparing Intracoronary Administration of Adenosine or Sodium Nitroprusside to Control for Attenuation of Microvascular Obstruction During Primary Percutaneous Coronary Intervention

• IRAS ID

  53469

• Contact name

  Anthony Gershlick

• Sponsor organisation

  University Hospitals of Leicester NHS Trust

• Eudract number

  2010-023211-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Patients with heart attacks are increasingly treated with balloons and stents (angioplasty) to open large arteries blocked by blood clots. Despite removing the blockage, blood flow to the heart muscle may not be fully restored due to poor flow in the down stream small blood vessels. This ??small vessel obstruction?? is of variable degrees and often hard to detect but when it occurs is associated with higher rates of repeat heart attacks, heart failure and death. Heart specialists do not know currently how best to limit ??small vessel obstruction??. Strategies to improve blood flow to the heart following angioplasty are very important to improve outcomes. This study lasts 24 months and will take place at two major hospitals in the UK: Glenfield Hospital (Leicester) and Leeds General Infirmary. 297 patients presenting within 6 hours of a heart attack will be allocated randomly to one of three groups: Group1. standard angioplasty (control). Groups 2 and 3 will receive standard therapy and either one of the study's two drugs, both of which may improve blood supply by limiting the amount of small vessel obstruction, and given via a very small tube placed close to the small downstream arteries (Group 2. adenosine and Group 3. sodium nitroprusside). The effectiveness of the drugs in reducing ??small vessel obstruction?? will be assessed using MRI scan. MRI can accurately quantify the amount of ??small vessel obstruction?? and degree of heart muscle damage that will ultimately form scar tissue. Importantly, the size of the heart attack and the degree of obstruction to blood flow on MRI are strongly related to subsequent complications following a heart attack. Additionally the effect of the drugs on how the clotting cells (platelets) function, which contribute to small vessel obstruction, will be assessed.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/H0405/10

• Date of REC Opinion

  27 Apr 2011

• REC opinion

  Further Information Favourable Opinion