Coronary Artery Disease Clinical Trial
— ICA-PIOfficial title:
Registry of Patients That Have Undergone an Invasive Coronary Angiography and/or Percutaneous Coronary Intervention
NCT number | NCT04815928 |
Other study ID # | ICA-PI |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | July 1, 2035 |
Verified date | June 2021 |
Source | VU University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | July 1, 2035 |
Est. primary completion date | July 1, 2035 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam Univeristy Medical centers, location VUmc | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fractional Flow Reserve (FFR) | Invasively obtained FFR | Upon inclusion at index procedure | |
Primary | Instantaneous wave-free ratio (iFR) | Invasively obtained iFR | Upon inclusion at index procedure | |
Primary | Quantitative Flow Ratio (QFR) | Invasively obtained QFR | Upon inclusion at index procedure | |
Primary | Stenosis percentage | Invasively obtained stenosis percentage | Upon inclusion at index procedure | |
Secondary | Major adverse cardiac events, cardiac death or repeat revascularization | The secondary endpoint is to assess the prognostic value of the obtained parameters. | 5 years |
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