Diagnostic and Prognostic Value of Angiography-derived IMR

NCT ID: NCT04825028

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 271 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-10-01

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: 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.

Conditions

Coronary Microvascular Dysfunction; Myocardial Ischemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Internal Diagnostic Accuracy Cohort

Consecutive patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery. In these patients, correlation between angiography-derived IMR and hyperemic microvascular resistance will be assessed.

Angiography-drived Index of Microcirculatory Resistance

Intervention Type: DEVICE

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.

External Diagnostic Accuracy Cohort

Patients are subgroup of previously published study (J Nucl Cardiol. 2020 Sep 30. doi: 10.1007/s12350-020-02252-8.), INOCA patients and normal controls confirmed by CZT-SPECT and angiography will be included for the assessment of angiography-derived IMR in diagnosing microvascular dysfunction.

Angiography-drived Index of Microcirculatory Resistance

Intervention Type: DEVICE

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.

Prognosis Cohort

Prognosis cohort, in which angiography-derived IMR will be measured in the target vessel after successful revascularization. Those patients have follow-up data after 2 years from index procedure.

Angiography-drived Index of Microcirculatory Resistance

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Angio-IMR; CaIMR

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junbo Ge, Professor

Role: STUDY_CHAIR

Fudan University

Locations

Shanghai Tenth People's Hospital

Shanghai, , China

Countries

China

Central Contacts

Neng Dai, MD

Role: CONTACT

niceday1987@hotmail.com

+8613701997266

Facility Contacts

Wenliang Che, MD, PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 32409977 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33391020 (View on PubMed)

Dai N, Che W, Liu L, Zhang W, Yin G, Xu B, Xu Y, Duan S, Yu H, Li C, Yao K, Huang D, Ge J. Diagnostic Value of Angiography-Derived IMR for Coronary Microcirculation and Its Prognostic Implication After PCI. Front Cardiovasc Med. 2021 Oct 15;8:735743. doi: 10.3389/fcvm.2021.735743. eCollection 2021.

Reference Type: DERIVED

PMID: 34722667 (View on PubMed)

Other Identifiers

ZS-20210328

Identifier Type: -

Identifier Source: org_study_id