Remote Ischemic Postconditioning in Humans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Hospital Universitario Virgen de la Victoria.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
FUNDACIÓN IMABIS
Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares
Information provided by (Responsible Party):
Hospital Universitario Virgen de la Victoria
ClinicalTrials.gov Identifier:
NCT01113008
First received: April 26, 2010
Last updated: January 18, 2012
Last verified: February 2011
  Purpose

The aim of this study is to evaluate the phenomenon of remote ischemic post-conditioning in humans. The minor myocardial damage associated with percutaneous revascularization procedures may be attenuated by producing controlled ischemia in the arms immediately after carrying out these procedures (remote ischemic post-conditioning). The justification and design of this clinical trial has been reported: Cardiology. 2011;119(3):164-9.


Condition Intervention
Myocardial Reperfusion Injury
Procedure: Remote ischemic postconditioning
Procedure: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Remote Ischemic Postconditioning. Can it Prevent Myocardial Injury During Percutaneous Coronary Intervention?

Further study details as provided by Hospital Universitario Virgen de la Victoria:

Primary Outcome Measures:
  • Maximum increase of troponin at 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Readmission due to acute coronary syndrome [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Readmission due to heart failure [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Cardiovascular mortality [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Enrollment: 320
Study Start Date: February 2009
Estimated Study Completion Date: May 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote postcondtioning
Patients assigned to remote ischemic postconditioning (randomized controlled trial)
Procedure: Remote ischemic postconditioning
Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated
Placebo Comparator: Control group Procedure: Control group
In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.

Detailed Description:

Percutaneous coronary intervention (PCI) has taken on an important role in the treatment of ischemic heart disease in recent years. However, the beneficial effects of revascularization are partly shadowed by post-reperfusion injury, which accounts for up to half the size of the reperfused myocardial infarct. Several drugs and procedures exist that might protect against this phenomenon. One of the most controversial of these strategies, which has shown promising results in experimental animal models, is remote ischemic post-conditioning. This involves inducing ischemia at a site remote from the heart after an ischemic coronary lesion to reduce the resulting myocardial infarct size.

The myocardial damage produced by ischemia-reperfusion associated with PCI is a known short- and long-term prognostic factor, and is associated with a greater risk of death, myocardial infarction and revascularization during the follow-up.

Our aim is to assess the phenomenon of remote ischemic post-conditioning in patients undergoing PCI, in whom the acute insult on the myocardium is determined by the angioplasty itself. Additionally, we aim to evaluate this phenomenon in a subgroup of diabetic patients, among whom the effectiveness of protective measures against post-reperfusion damage is more questioned.

We have designed a randomized, single-blinded interventional study involving 320 patients (40% diabetics) who are to undergo elective PCI. At the end of the angioplasty procedure, the patients assigned to remote ischemic post-conditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated. In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.

The infarct size will be analyzed from an enzyme curve of troponin I and CK-MB values 0, 8, 16 and 24 hours after the procedure (primary endpoint). Measurements will also be taken of pH and lactate in the baseline sample (0 hours) and at 8 hours, and ultrasensitive C-reactive protein at 0 and 24 hours as a contrasted marker of inflammation in ischemic heart disease.

The follow-up, planned for one year, will seek to determine clinically interesting variables (secondary endpoint), such as readmission due to acute coronary syndrome, heart failure or major arrhythmic events and overall and cardiovascular mortality.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing PCI due to stable angina
  2. Patients undergoing PCI due to unstable angina
  3. Patients undergoing PCI due NON Q acute myocardial infarction with normal troponin at inclusion moment (less than 1 ng/ml)

Exclusion Criteria:

  1. Acute myocardial infarction during the previous two weeks
  2. Chronic renal failure with baseline creatinine above 3 mg/dL

4. Collateral circulation of the revascularized artery (Rantrop >0) 5. Prior treatment with glibenclamide. 6. Inability to receive follow-up, blood test or lack of informed consent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113008

Locations
Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain, 29010
Sponsors and Collaborators
Hospital Universitario Virgen de la Victoria
FUNDACIÓN IMABIS
Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares
Investigators
Principal Investigator: Manuel F Jiménez-Navarro, Doctor Servicio Cardiología, Hospital Universitario Virgen de la Victoria
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitario Virgen de la Victoria
ClinicalTrials.gov Identifier: NCT01113008     History of Changes
Other Study ID Numbers: PI-0327/2008
Study First Received: April 26, 2010
Last Updated: January 18, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitario Virgen de la Victoria:
Myocardial Reperfusion Injury/mortality
Coronary angioplasty
Reperfusion
Myocardial Reperfusion Injury/prevention & control

Additional relevant MeSH terms:
Myocardial Reperfusion Injury
Reperfusion Injury
Cardiomyopathies
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Postoperative Complications
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014