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Plaque Burden Pre- Myocardial Revascularisation (ByPlaque)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774004
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Brief Summary:

The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG).

Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the internal thoracic arteries will be evaluated additionally with US. These parameters will be measured pre-CABG.

Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.


Condition or disease
Atherosclerosis

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 1, 2021



Primary Outcome Measures :
  1. Association of MACE rates with peripheral atherosclerotic volume [ Time Frame: 5 years ]
  2. Association of morbidity with peripheral atherosclerotic volume [ Time Frame: 5 years ]
    Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"


Secondary Outcome Measures :
  1. Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions [ Time Frame: 1 year ]
    Risk scores include STS Score and Euro Score

  2. Association of the duration of the operation with peripheral atherosclerotic volume [ Time Frame: 30 days ]
  3. Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates [ Time Frame: 5 years ]
  4. Association of the aortic clamp time with peripheral atherosclerotic volume [ Time Frame: 30 days ]
  5. Association of the ICU stay with peripheral atherosclerotic volume [ Time Frame: 30 days ]
  6. Association of the hospitalization duration with peripheral atherosclerotic volume [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients, who are are listed for elective CABG at the Medical University Innsbruck will be screened and recruited.
Criteria

Inclusion Criteria:

  • pre CABG

Exclusion Criteria:

  • no consent, prior carotid intervention

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): NCT03774004


Contacts
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Contact: Michael Schreinlechner, MD 004351250481308 Michael.Schreinlechner@i-med.ac.at
Contact: Peter Marschang, MD Peter.Marschang@i-med.ac.at

Locations
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Austria
Medical University of Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Michael Schreinlechner, MD    004351250481308    Michael.Schreinlechner@i-med.ac.at   
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Peter Marschang, MD Medical University Innsbruck
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03774004    
Other Study ID Numbers: 1098/2017
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases