Cardioprotection in CABG and AVR patients with RIPC

Completed

• Conditions: Topic: Cardiovascular; Disease: Cardiovascular; Circulatory System; Subtopic: Cardiovascular (all Subtopics)

• Registration Number: ISRCTN33084113
• Lead Sponsor: Imperial College London (UK)

Brief Summary

1. 2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25899533 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30544237

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-25
• Study Completion: 2015-06-30
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Current inclusion criteria as of 03/11/2014:
1. Age =18
2. Patients undergoing elective (or urgent) first-time CABG or AVR

Previous inclusion criteria:
1. Male and female, age >=40 and <85 years
2. Patients undergoing elective (or urgent) first-time CABG or AVR

Exclusion Criteria

Current exclusion criteria as of 03/11/2014:
1. Cardiogenic shock or cardiac arrest,
2. Significant peripheral arterial disease affecting upper limbs,
3. Renal failure (with a GFR < 30 ml/min/1.73m2),
4. Glibenclamide or nicorandil (as these medications may interfere with RIPC)
5. Participation in another interventional study.
6. Neither upper limb available for the intervention

Previous exclusion criteria:
1. Cardiogenic shock or cardiac arrest
2. Significant peripheral arterial disease affecting upper limbs
3. Hepatic dysfunction (Bilirubin > 20 mmol/L, Prothrombin > 2.0 ratio)
4. Pulmonary disease (FEV1 < 40% predicted)
5. Renal failure (with a GFR < 30 ml/min/1.73m2)
6. Glibenclamide or nicorandil (as these medications may interfere with RIPC)
7. Participation in another interventional study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial Injury; Timepoint(s): 2 pre-operatively and 6, 12, 24, 48 and 72 hours after end of cardioplegic arrest

Secondary Outcome Measures

Name	Time	Method
<br> 1. Clinical endpoints measured from admission up till 3 months post-operatively<br> 2. Inflammatory and oxidative stress measured two pre-operatively and 5 postoperatively at 6, 12, 24, 48 & 72 hours after end of cardioplegic arrest<br>