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The Acute and Chronic Effects of Remote Ischemic Conditioning on Cardiovascular Function

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ClinicalTrials.gov Identifier: NCT03984123
Recruitment Status : Active, not recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

Brief Summary:
The investigators are going to examine 180 patients within 48h of STEMI. The investigators utilise either a double -with a 15- min intervening interval-, or a single ischemic stimulus by brachial cuff inflation of both arms at 200mmHg for 5 min. Each ischemic stimulus is folloThe investigatorsd by a vascular function assessment, with a final assessment 25 minutes after the second cuff deflation. All patients undergo a sham cuff inflation. The investigators measure: a) the perfusion boundary region (PBR-micrometers) of the sublingual arterial microvessels as a marker of endothelial glycocalyx thickness to assess vascular permeability, b) the carotid-femoral pulse wave velocity (PWV). At baseline (T0) and the last vascular assessment (T3) The researchers also measure microRNA-144,-150,-499 (cardioprotective action), -21, and -208 (remodeling stimuli) expression, nitrate- nitrite (NOx) and malondialdehyde (MDA) plasma levels. Moreover, the investigators are going to perform an echocardiographic study 2 years after the recruitment to investigate whether the left ventricular function differs among the arms of intervention.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Brachial cuff, in order to achieve ischemic stimuli Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: The Acute and Chronic Effects of Remote Ischemic Conditioning on Endothelial Glycocalyx Integrity, Cardiovascular Function and Biomarkers
Actual Study Start Date : June 27, 2014
Estimated Primary Completion Date : July 10, 2019
Estimated Study Completion Date : November 18, 2019

Arm Intervention/treatment
Double cuff inflation
The first arm utilizes two ischemic stimuli by brachial cuff inflation of both arms at 200 mmHg for 5 minutes, separated by 15 minutes, after a baseline vascular function assessment (T0). Each ischemic stimulus is followed by a vascular function assessment (T1, T2), with a final assessment 25 minutes after the second cuff deflation (T3). All measurements are preceded by a sham conditioning procedure, by way of cuff inflation omission after their placement around the ordinary brachial position. Blood samples are drawn at baseline (T0) and at the termination of each protocol (T3).
Device: Brachial cuff, in order to achieve ischemic stimuli
Single cuff inflation
The second arm utilizes two ischemic stimuli by brachial cuff inflation of both arms at 200 mmHg for 5 minutes, separated by 15 minutes, after a baseline vascular function assessment (T0). Each ischemic stimulus is followed by a vascular function assessment (T1, T2), with a final assessment 25 minutes after the second cuff deflation (T3). All measurements are preceded by a sham conditioning procedure, by way of cuff inflation omission after their placement around the ordinary brachial position. Blood samples are drawn at baseline (T0) and at the termination of each protocol (T3).
Device: Brachial cuff, in order to achieve ischemic stimuli



Primary Outcome Measures :
  1. Changes of aortic stiffness among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning [ Time Frame: Baseline,10 minutes, 25 minutes, 45 minutes ]
    Changes of carotid - femoral Pulse Wave Velocity among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning


Secondary Outcome Measures :
  1. Changes of endothelial glycocalyx integrity among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning [ Time Frame: Baseline,10 minutes, 25 minutes, 45 minutes ]
    Changes of perfusion boundary region (PBR) of sublingual arterial microvasculature (diameter span from 5 to 25 μm) among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning

  2. Changes of oxidative stress biomarkers among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning [ Time Frame: Baseline, 45 minutes ]
    Changes of malondialdehyde plamsa levels concetrations among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning

  3. Changes of micro RNA expression among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning [ Time Frame: Baseline, 45 minutes ]
    Changes of miR144, miR150, miR499, miR21, miR145, miR208a expression among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning

  4. Changes of Nitrate-nitrite-nitric oxide plasma concetrations among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning [ Time Frame: Baseline, 45 minutes ]
    Changes of Nitrate-nitrite-nitric oxide plasma concetrations among interventions arms at baseline and during the acute phase of Remote Ischemic Conditioning

  5. Differences of left ventricular function among interventions arms at the chronic phase of Remote Ischemic Conditioning [ Time Frame: Baseline, 2 years ]
    Differences of left ventricular end systolic volume among interventions arms at the chronic phase of Remote Ischemic Conditioning

  6. Changes of aortic stiffness among interventions arms at the chronic phase of Remote Ischemic Conditioning [ Time Frame: Baseline, 2 years ]
    Changes of carotid - femoral Pulse Wave Velocity among interventions arms at the chronic phase of Remote Ischemic Conditioning

  7. Changes of endothelial glycocalyx integrity among interventions arms at the chronic phase of Remote Ischemic Conditioning [ Time Frame: Baseline,2 years ]
    Changes of perfusion boundary region (PBR) of sublingual arterial microvasculature (diameter span from 5 to 25 μm) among interventions arms at the chronic phase of Remote Ischemic Conditioning



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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject suffered a STEMI within 48 hours
  • Subject underwent PCI within 48 hours

Exclusion Criteria:

  • Subject has known coronary artery disease or other cardiovascular disease.
  • Subject has Killip class >2 during index event
  • Subject received nitrates
  • Subject suffers from inflammatory disease.
  • Subject suffers from systematic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984123


Locations
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Greece
"Attikon" University General Hospital
Athens, Attiki, Greece, 12462
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Dimitrios Vlastos, MD 2nd Cardiology Department, University of Athens, Greece
Principal Investigator: Efstathios K. Iliodromitis, MD, PhD 2nd Cardiology Department, University of Athens, Greece

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Responsible Party: Ignatios Ikonomidis, Associate Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT03984123     History of Changes
Other Study ID Numbers: 301/27-6-14
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ignatios Ikonomidis, University of Athens:
Remote Ischemic Conditioning
Endothelial glycocalyx
Arterial stiffness
micro RNA
NO pathway

Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases