Trials / Unknown
UnknownNCT05825339
Absolute Flow for Ischemia With No Obstructive Coronary Arteries
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 121 (estimated)
- Sponsor
- Spanish Society of Cardiology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The main objective is to prospectively validate the capacity of continuous thermodilution coronary flow reserve (CFRflow) as a predictor of the presence of angina measured by SAQ7 in patients with INOCA at 3 months. Secondary objectives include identifying hemodynamic factors related to the persistence of angina at 3 and 12 months, identifying clinical factors associated with the persistence of angina, establishing the prevalence of patients with coronary microvascular dysfunction within the cohort of INOCA patients, identifying predictors of major cardiovascular events at 12 months, validating the pathological value of MMR and establishing the pathological value of AF measured in ml/min. The study also aims to evaluate the concordance between measures of the coronary microvascular function obtained by continuous thermodilution and bolus thermodilution, as well as their concordance with clinical characteristics.
Detailed description
Invasive study of microvascular function has become highly relevant for the diagnosis of alterations in coronary physiology for diagnostic, prognostic, and therapeutic purposes. Currently, the microvascular resistance index (IMR) is considered the gold standard for invasive diagnosis of coronary microvascular function, with a recommendation of 2A in the current clinical practice guidelines of the European Society of Cardiology. In recent years, technical innovation has allowed for the measurement of absolute coronary flow (AF) and minimal microvascular resistance (MMR) using continuous thermodilution, enabling the determination of quantitative flow and resistance units. However, the main limitation is the absence of reference values. Objectives: The main objective is to prospectively validate the capacity of CFRflow as a predictor of the presence of angina measured by SAQ7 in patients with INOCA at 3 months. Secondary objectives include identifying hemodynamic factors related to the persistence of angina at 3 and 12 months, identifying clinical factors related to the persistence of angina, establishing the prevalence of patients with coronary microvascular dysfunction within the cohort of INOCA patients, identifying predictors of major cardiovascular events at 12 months, validating the pathological value of MMR and establishing the pathological value of AF measured in ml/min. The study also aims to evaluate the concordance between measures of the coronary microvascular function obtained by continuous thermodilution and bolus thermodilution, as well as their concordance with clinical characteristics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Coronary Flow Reserve | Diagnostic of Microvascular Coronary Dysfunction using continuous thermodilution flow reserve |
Timeline
- Start date
- 2021-05-01
- Primary completion
- 2024-04-30
- Completion
- 2024-06-30
- First posted
- 2023-04-24
- Last updated
- 2023-04-24
Locations
6 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05825339. Inclusion in this directory is not an endorsement.