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Registry of Patients That Have Undergone ICA or PCI (ICA-PI)

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ClinicalTrials.gov Identifier: NCT04815928
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Paul Knaapen, VU University Medical Center

Study Description
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Brief Summary:
In Invasive Coronary Angiography there are multiple invasively obtained measurements to determine the funcitonal significance of Cornary Artery Disease. In this Registry, patients who have undergone Invasive Coronary Angiography or Percutaneous Coronary Intervention are included to investigate diagnostic and prognostic implications of the invasive measurements.

Condition or disease
Coronary Artery Disease

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Registry of Patients That Have Undergone an Invasive Coronary Angiography and/or Percutaneous Coronary Intervention
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2035
Estimated Study Completion Date : July 1, 2035
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Fractional Flow Reserve (FFR) [ Time Frame: Upon inclusion at index procedure ]
    Invasively obtained FFR

  2. Instantaneous wave-free ratio (iFR) [ Time Frame: Upon inclusion at index procedure ]
    Invasively obtained iFR

  3. Quantitative Flow Ratio (QFR) [ Time Frame: Upon inclusion at index procedure ]
    Invasively obtained QFR

  4. Stenosis percentage [ Time Frame: Upon inclusion at index procedure ]
    Invasively obtained stenosis percentage


Secondary Outcome Measures :
  1. Major adverse cardiac events, cardiac death or repeat revascularization [ Time Frame: 5 years ]
    The secondary endpoint is to assess the prognostic value of the obtained parameters.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients that have undergone an invasive coronary angiography and or/percutaneous coronary intervention
Criteria

Inclusion Criteria:

  • 18 years
  • Has undergone or will undergo a clinically indicated invasive coronary angiography.
  • Has undergone or will undergo a clinically indicated percutaneous coronary intervention.

Exclusion Criteria:

  • Not willing / unable to provide informed consent.
Contacts and Locations
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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): NCT04815928


Locations
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Netherlands
Amsterdam Univeristy Medical centers, location VUmc Recruiting
Amsterdam, Netherlands
Contact: Ruurt Jukema, MD, PhD student    +3120-4443272    r.jukema@amsterdamumc.nl   
Sponsors and Collaborators
VU University Medical Center
More Information
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Responsible Party: Paul Knaapen, Principal Investigator, VU University Medical Center
ClinicalTrials.gov Identifier: NCT04815928    
Other Study ID Numbers: ICA-PI
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021

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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 Paul Knaapen, VU University Medical Center:
Quantiative Flow Ratio
QFR
Fractional Flow Reserve
FFR
 Instantaneous wave-free ratio
iFR
Invasive Coronary Angiography
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases