Simultaneous Assessment of Coronary Microvascular Dysfunction and Ischemia With Non-obstructed Coronary Arteries With Intracoronary Electrocardiogram and Intracoronary Doppler

NCT ID: NCT05471739

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2022-10-15

Brief Summary

Coronary Microvascular Dysfunction has been consistently shown to play a considerable role in pathophysiology of Ischaemia with non-obstructed coronary arteries (INOCA). While the both diagnoses are individually related to remarkably worse outcome, there is no available method to simultaneously determine INOCA-CMD endotypes in vessel level, during the invasive diagnosis.

The investigators hereby hypothesize that, combined intracoronary electrocardiogram (IC-ECG) (considering the high sensitivity and specificity of IC-ECG for studied vessel-territory) and intracoronary doppler can simultaneously and successfully identify vessel specific coronary microvascular dysfunction and resulting ischemia, which may potentially enable immediate diagnosis and endotyping of CMD-INOCA subgroups during the invasive assessment of first ANOCA episode, obviating the need for further ischemia-studies such es SPECT, which have considerably higher costs and lower sensitivity.

Major coronary arteries of patients aged between 18 - 75 without obstructing coronary artery disease who have previously documented ischemia with non-obstructed coronary arteries (INOCA) via coronary angiogram and myocardial perfusion scan will be evaluated simultaneously with IC-ECG and intracoronary Doppler during rest and under adenosine induced hyperaemia.

Performance of the combined system to identify Coronary Microvascular Dysfunction with structural and functional subgroups as defined by abnormal Coronary Flow Reserve (CFR) and Hyperemic Microvascular Resistance (HMR) and Ischemia in downstream territories of same vessel area (as defined by perfusion scan) is intended to be determined.

The investigators also intend to interrogate the possible relationship between dynamic changes in IC-ECG parameters and invasively obtained intracoronary hemodynamic data.

Detailed Description

Background and Rationale of Study

Coronary Microvascular Dysfunction has been consistently shown to play a considerable role in pathophysiology of Ischaemia with non-obstructed coronary arteries (INOCA). While the both diagnoses are individually related to remarkably worse outcome, there is no available method to simultaneously determine INOCA-CMD endotypes in vessel level, during the invasive diagnosis.

Hypothesis

The investigators hereby hypothesize that, combined intracoronary electrocardiogram (IC-ECG) (considering its high sensitivity for ischemia and specificity for studied vessel-territory) and intracoronary doppler can simultaneously and successfully identify vessel specific coronary microvascular dysfunction and resulting ischemia, which may potentially enable immediate diagnosis and endotyping of CMD-INOCA subgroups during the invasive assessment of first ANOCA episode, obviating the need for further ischemia-studies such as SPECT, which have considerably higher costs and lower sensitivity and requires more hospital visits.

Study Method

Major coronary arteries of patients aged between 18 - 75 without obstructing coronary artery disease who have previously documented ischaemia with non-obstructed coronary arteries (INOCA) via coronary angiogram and myocardial perfusion scan will be evaluated simultaneously with IC-ECG and intracoronary Doppler during rest and under adenosine induced hyperaemia after obtaining informed consent. Flow (APVr, APVh) data will be collected via intracoronary doppler during rest and adenosine induced hyperaemia in concordance with guidelines and Coronary Flow Reserve will be determined. Microvascular resistances (HMR, BMR) will be calculated with distal pressures and flow data.

Simultaneous with intracoronary Doppler, IC-ECG records will be obtained during rest and hyperaemia. Paper records will be digitized offline in MATLAB environment. Delta ST, Delta ST integral, Delta T, Delta T integral will be measured and calculated and quantified as continuous values.

All participants will be go through careful medical evaluation and presence of exclusion criteria will be assessed.

At the end of the data collection period, all available major coronary arteries are expected to have:

1. Myocardial Perfusion Scan result: whether they relate to (supply blood) ischemic territory.

2. Structural/Functional Microvascular Status: (CFR and HMR)

-Definition of Coronary Microvascular Dysfunction and Subgroups: CMD is defined as CFR < 2.5. Those with concomitant HMR > 1.9 will be further labeled as structural CMD whereas vessels with CFR <2.5 and HMR <1.9 will be labeled as functional CMD.

3. IC-ECG parameters

Conditions

Coronary Microvascular Dysfunction; Coronary Microvascular Disease; Non-Obstructive Coronary Atherosclerosis; Microvascular Angina; Microvascular Coronary Artery Disease; Ischemic Heart Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• ≥1 previous episode of typical angina pectoris with normal coronary angiograms (Angina with Non-obstructed Coronary Arteries)
• positive myocardial perfusion scan (MPS) for ischemia or slow-flow.

Exclusion Criteria

• obstructive epicardial coronary artery disease of at least 1 coronary artery in angiogram
• lung disease causing severe bronchospasm
• NYHA III - IV Heart Failure
• Bundle Branch Block
• Hb < 10 g/dL
• Active Malignancy
• Active Infection
• Morbid Obesity
• Pacemaker (Actively Pacing)
• Peripheral Artery Disease
• Previous CABG
• Chronic Hypoxia due to lung diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Murat Sezer

MD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

PMID: 34593129 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 29031990 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 34125855 (View on PubMed)

Cevik E, Tas A, Demirtakan ZG, Damman P, Alan Y, Broyd CJ, Ozcan A, Simsek DH, Sonsoz MR, Royen NV, Perera D, Davies JE, Umman S, Sezer M. Intracoronary electrocardiogram detects coronary microvascular dysfunction and ischemia in patients with no obstructive coronary arteries disease. Am Heart J. 2024 Apr;270:62-74. doi: 10.1016/j.ahj.2024.01.003. Epub 2024 Jan 25.

Reference Type: DERIVED

PMID: 38278503 (View on PubMed)

Hasdemir H, Tas A, Cevik E, Alan Y, Broyd CJ, Ozcan A, Sonsoz MR, Kara I, Demirtakan ZG, Parker K, Perera D, Umman S, Sezer M. Primary versus iatrogenic (post-PCI) coronary microvascular dysfunction: a wire-based multimodal comparison. Open Heart. 2023 Nov 27;10(2):e002437. doi: 10.1136/openhrt-2023-002437.

Reference Type: DERIVED

PMID: 38011991 (View on PubMed)

Other Identifiers

2019/1285

Identifier Type: -

Identifier Source: org_study_id