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

June 2, 2021 updated by: Paul Knaapen, Amsterdam UMC, location VUmc

Registry of Patients That Have Undergone an Invasive Coronary Angiography and/or Percutaneous Coronary Intervention

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam Univeristy Medical centers, location VUmc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients that have undergone an invasive coronary angiography and or/percutaneous coronary intervention

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional Flow Reserve (FFR)
Time Frame: Upon inclusion at index procedure
Invasively obtained FFR
Upon inclusion at index procedure
Instantaneous wave-free ratio (iFR)
Time Frame: Upon inclusion at index procedure
Invasively obtained iFR
Upon inclusion at index procedure
Quantitative Flow Ratio (QFR)
Time Frame: Upon inclusion at index procedure
Invasively obtained QFR
Upon inclusion at index procedure
Stenosis percentage
Time Frame: Upon inclusion at index procedure
Invasively obtained stenosis percentage
Upon inclusion at index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2035

Study Completion (Anticipated)

July 1, 2035

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICA-PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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