Diagnostic and Prognostic Value of Angiography-derived IMR

Myocardial Ischemia Clinical Trial

— CHART-MiCro  

Official title:

Diagnostic Value of Angiography-derived Index of Microvascular Resistance in Coronary Artery Disease Patients and Its Prognostic Implication After Percutaneous Coronary Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04825028
• Other study ID #: ZS-20210328
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Neng Dai, MD
• Phone: +8613701997266
• Email: niceday1987[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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: 10.1007/s12350-020-02252-8.) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 271
• Est. completion date: October 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• CAD patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery (Cohort 1)
• INOCA patients and normal controls confirmed by CZT-SPECT and angiography (Cohort 2)
• Stable CAD patients received PCI (Cohort 3)
• analyzable angiograms at the index procedure

Exclusion Criteria:

• Previous coronary artery bypass grafting
• Chronic total occlusion patients
• limited image quality of coronary angiography
• Insufficient angiographic project for TIMI frame count
• Severe tortuosity of target vessel
• No optimal projection for reconstruction

Related Conditions & MeSH terms

• Coronary Microvascular Dysfunction
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Angiography-drived Index of Microcirculatory Resistance
From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation. Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}). Hyperemic Pa will be estimated from resting Pa according to prespecified equation.

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Ai H, Feng Y, Gong Y, Zheng B, Jin Q, Zhang HP, Sun F, Li J, Chen Y, Huo Y, Huo Y. Coronary Angiography-Derived Index of Microvascular Resistance. Front Physiol. 2020 Dec 16;11:605356. doi: 10.3389/fphys.2020.605356. eCollection 2020. — View Citation

De Maria GL, Scarsini R, Shanmuganathan M, Kotronias RA, Terentes-Printzios D, Borlotti A, Langrish JP, Lucking AJ, Choudhury RP, Kharbanda R, Ferreira VM; Oxford Acute Myocardial Infarction (OXAMI) Study Investigators, Channon KM, Garcia-Garcia HM, Banning AP. Angiography-derived index of microcirculatory resistance as a novel, pressure-wire-free tool to assess coronary microcirculation in ST elevation myocardial infarction. Int J Cardiovasc Imaging. 2020 Aug;36(8):1395-1406. doi: 10.1007/s10554-020-01831-7. Epub 2020 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Correlation between angiography-derived IMR and HMR	at the index procedure
Primary	Major adverse cardiac events	Major adverse cardiac events (MACE), including cardiac death and readmission due to heart failure.	at 28 months from index procedure
Secondary	A composite of cardiac death, readmission due to heart failure and angina	A composite of cardiac death, readmission due to heart failure and angina	at 28 months from index procedure
Secondary	A composite of cardiac death, readmission due to heart failure, spontaneous MI, target vessel revascularization and angina	A composite of cardiac death, readmission due to heart failure, spontaneous MI, target vessel revascularization and angina.	at 28 months from index procedure
Secondary	Cardiac death	Cardiac death	at 28 months from index procedure
Secondary	Readmission due to heart failure	Readmission due to heart failure	at 28 months from index procedure
Secondary	Spontaneous MI	Spontaneous MI	at 28 months from index procedure
Secondary	Target vessel revascularization	Target vessel revascularization	at 28 months from index procedure
Secondary	Readmission due to angina	Readmission due to angina	at 28 months from index procedure