Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04825028
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2021-03-28
Brief Title:
Diagnostic and Prognostic Value of Angiography-derived IMR
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Diagnostic Value of Angiography-derived Index of Microvascular Resistance in Coronary Artery Disease Patients and Its Prognostic Implication After Percutaneous Coronary Intervention
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHART-MiCro
Brief Summary:
The importance of the microvasculature in determining clinical outcomes has been highlighted in patients with coronary artery disease CAD For patients with stable CAD despite the success of percutaneous coronary intervention PCI in relieving a stenosis in the epicardial coronary artery microvascular dysfunction may preclude sufficient coronary flow and myocardial perfusion possibly leading to worse clinical outcome With the technical development of computational fluid dynamics angiographic derivation of index of Index of Microcirculatory Resistance IMR without pressure wire hyperemic agents or theromdilution method is available as a potential alternative for pressure wire-derived IMR In this regard the current study will evaluate diagnostic implication of angiography-derived IMR and its prognostic implication after PCI in patients with stable CAD
Detailed Description:
The importance of the microvasculature in determining clinical outcomes has been highlighted in patients with coronary artery disease CAD For patients with stable CAD despite the success of percutaneous coronary intervention PCI in relieving a stenosis in the epicardial coronary artery microvascular dysfunction may preclude sufficient coronary flow and myocardial perfusion possibly leading to worse clinical outcome With the technical development of computational fluid dynamics angiographic derivation of IMR without pressure wire hyperemic agents or theromdilution method is available as a potential alternative for pressure wire-derived IMR In this regard the current study will evaluate diagnostic implication of angiography-derived IMR and its prognostic implication after PCI in patients with stable CAD
This study cohorts consist with 3 separate cohort first internal diagnostic accuracy cohort which will evaluate correlation between angiography-derived IMR and hyperemic microvascular resistance calculated using Cadmium-Zinc-Telluride Single-Photon Emission Computed Tomography CZT-SPECT-derived myocardial blood flow and invasively measured pressure data For this 53 consecutive patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery will be evaluated Second external diagnostic cohort in which diagnostic accuracy of angiography-derived IMR will be assessed in patients with ischemia and no obstructive coronary artery disease INOCA and normal controls whose results were previously published J Nucl Cardiol 2020 Sep 30 doi 101007s12350-020-02252-8 Among this cohort 45 patients with no obstructive CAD and normal CZT-SPECT perfusion imaging will be regarded as normal controls in 35 INOCA patients vessels with normal corresponding perfusion territory will be regarded as internal control Third prognosis cohort in which 138 consecutive CAD patients received PCI with available angiograms and who were suitable for angiographic fractional flow reserve and IMR measurement will be analyzed Primary clinical outcome will be cardiac death or congestive heart failure at 2 years from index procedure Secondary outcome will be any myocardial infarction ischemia-driven revascularization definite or probable stent thrombosis congestive heart failure admission and angina pectoris admission at 2 years from index procedure
This study cohorts consist with 3 separate cohort first internal diagnostic accuracy cohort which will evaluate correlation between angiography-derived IMR and hyperemic microvascular resistance calculated using Cadmium-Zinc-Telluride Single-Photon Emission Computed Tomography CZT-SPECT-derived myocardial blood flow and invasively measured pressure data For this 53 consecutive patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery will be evaluated Second external diagnostic cohort in which diagnostic accuracy of angiography-derived IMR will be assessed in patients with ischemia and no obstructive coronary artery disease INOCA and normal controls whose results were previously published J Nucl Cardiol 2020 Sep 30 doi 101007s12350-020-02252-8 Among this cohort 45 patients with no obstructive CAD and normal CZT-SPECT perfusion imaging will be regarded as normal controls in 35 INOCA patients vessels with normal corresponding perfusion territory will be regarded as internal control Third prognosis cohort in which 138 consecutive CAD patients received PCI with available angiograms and who were suitable for angiographic fractional flow reserve and IMR measurement will be analyzed Primary clinical outcome will be cardiac death or congestive heart failure at 2 years from index procedure Secondary outcome will be any myocardial infarction ischemia-driven revascularization definite or probable stent thrombosis congestive heart failure admission and angina pectoris admission at 2 years from index procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None