Trials / Completed
CompletedNCT04485234
Inclusive Invasive Physiological Assessment in Angina Syndromes Registry
Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,322 (actual)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the prognostic value and potential therapeutic impact of combined pressure and flow measurements in the evaluation of epicardial coronary stenosis and microvascular function.
Detailed description
ILIAS registry is a global effort to gather lesion-level data on the diagnostic and prognostic value of combined coronary pressure and flow measurements in clinical practice. Data is gathered from 7 nations (The Netherlands, Korea, Japan, Spain, Italy, Denmark, USA), using either coronary Doppler velocity measurements or coronary thermodilution measurements to obtain invasive coronary flow assessment. Patient treatment was governed by the local clinical practice guidelines at the time of the invasive procedure, but was at the operator's discretion. A standardized data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel evaluation was used.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance | Calculation of the resting mean distal coronary to aortic pressure ratio (resting Pd/Pa), fractional flow reserve (Pd/Pa at hyperemia), Coronary flow reserve (peak flow/resting flow), microvascular resistance (Pd/flow). |
Timeline
- Start date
- 2019-06-01
- Primary completion
- 2021-03-25
- Completion
- 2021-03-25
- First posted
- 2020-07-24
- Last updated
- 2021-03-29
Locations
12 sites across 7 countries: United States, Denmark, Italy, Japan, Netherlands, South Korea, Spain
Source: ClinicalTrials.gov record NCT04485234. Inclusion in this directory is not an endorsement.