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AzTrials

Coronary Microvascular DysfunctionCHART-MiCroNCT04825028

Diagnostic and Prognostic Value of Angiography-derived IMR

An observational study of Coronary Microvascular Dysfunction and Myocardial Ischemia, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Angiography-drived Index of Microcirculatory Resistance
Type of treatment
Medical device
How many people
271 participants
Where
1 siteChina
Study dates
1 Apr 2021to 1 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Diagnostic Accuracy Cohort, 53 stable CAD patients who underwent CZT-SPECT MBF and invasive pressure measurements in LAD within 7 days. Diagnostic Accuracy Cohort, 35 INOCA patients confirmed by CZT-SPECT and coronary angiography and 45 normal controls Prognosis Cohort 138 stable patients received PCI with available angiograms and who were suitable for angiographic FFR and IMR measurement and have 28 months follow-up data.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Neng Dai, MD contact

+8613701997266

niceday1987@hotmail.com

China1 site

  • Shanghai Tenth People's Hospital

    Shanghai, 200091

    Wenliang Che, MD, PhD

    Wenliang Che, MD, PhD

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Angiography-drived Index of Microcirculatory Resistance
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Angiography-drived Index of Microcirculatory ResistanceDevice

    Also called Angio-IMR, CaIMR

    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.

Study groups in NCT04825028
Study groupRoleWhat they receive
Internal Diagnostic Accuracy CohortConsecutive 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.
Receives: Device: Angiography-drived Index of Microcirculatory Resistance
External Diagnostic Accuracy CohortPatients 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.
Receives: Device: Angiography-drived Index of Microcirculatory Resistance
Prognosis CohortPrognosis 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.
Receives: Device: Angiography-drived Index of Microcirculatory Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy

    Correlation between angiography-derived IMR and HMR

    Measured: at the index procedure

  2. Major adverse cardiac events

    Major adverse cardiac events (MACE), including cardiac death and readmission due to heart failure.

    Measured: at 28 months from index procedure

Secondary outcomes (7)

  1. A composite of cardiac death, readmission due to heart failure and angina

    A composite of cardiac death, readmission due to heart failure and angina

    Measured: at 28 months from index procedure

  2. 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.

    Measured: at 28 months from index procedure

  3. Cardiac death

    Cardiac death

    Measured: at 28 months from index procedure

  4. Readmission due to heart failure

    Readmission due to heart failure

    Measured: at 28 months from index procedure

  5. Spontaneous MI

    Spontaneous MI

    Measured: at 28 months from index procedure

  6. Target vessel revascularization

    Target vessel revascularization

    Measured: at 28 months from index procedure

  7. Readmission due to angina

    Readmission due to angina

    Measured: at 28 months from index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start1 Apr 2021 (estimated)
  3. Primary completion1 May 2021 (estimated)
  4. Study completion1 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
271 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04825028
Sponsor's protocol ID
ZS-20210328
Acronym
CHART-MiCro
Status last verified
Mar 2021
First submitted
28 Mar 2021
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32409977

  • 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.

    PubMed 33391020

  • 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.

    PubMed 34722667

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Microvascular Dysfunction and Myocardial Ischemia, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Neng Dai, MD (+8613701997266, niceday1987@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy (time frame: at the index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04825028, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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