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

NCT05471739 | Completed

• 1 other identifier: 2019/1285
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

INOCA; ANOCA; CMD; Coronary Microvascular Dysfunction; Ischemia with non-obstructive coronary arteries; Coronary Microvascular Disease; Microvascular Angina

Outcome Measures

Primary Outcomes (4)

• Hyperemic Microvascular Resistance (HMR)

  the ratio of mean distal coronary pressure to average flow velocity

  Intraprocedural during coronary angiography

• Coronary Flow Reserve (CFR)

  the ratio between coronary blood flow at maximal hyperemia and at baseline condition

  Intraprocedural during coronary angiography

• Delta ST

  absolute shift of ST segment in IC-ECG record (at J point)

  Intraprocedural during coronary angiography

• Delta ST Integral

  absolute change in area between ST segment and isoelectric line

  Intraprocedural during coronary angiography

Secondary Outcomes (2)

• Resting Average Peak Velocity

  Intraprocedural during coronary angiography

• Hyperemic Average Peak Velocity

  Intraprocedural during coronary angiography

Other Outcomes (1)

• Basal Microvascular Resistance (BMR)

  Intraprocedural during coronary angiography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18 - 75 years old patients with previously documented ischemia with non-obstructed coronary arteries and positive ischemia test (myocardial perfusion scan or slow-flow) to be enrolled. Patients meeting at least one exclusion criteria won't be enrolled.

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, 34290, Turkey (Türkiye)

Location

Related Publications (6)

• Jansen TPJ, Konst RE, Elias-Smale SE, van den Oord SC, Ong P, de Vos AMJ, van de Hoef TP, Paradies V, Smits PC, van Royen N, Damman P. Assessing Microvascular Dysfunction in Angina With Unobstructed Coronary Arteries: JACC Review Topic of the Week. J Am Coll Cardiol. 2021 Oct 5;78(14):1471-1479. doi: 10.1016/j.jacc.2021.08.028.

  PMID: 34593129 BACKGROUND

• Ong P, Camici PG, Beltrame JF, Crea F, Shimokawa H, Sechtem U, Kaski JC, Bairey Merz CN; Coronary Vasomotion Disorders International Study Group (COVADIS). International standardization of diagnostic criteria for microvascular angina. Int J Cardiol. 2018 Jan 1;250:16-20. doi: 10.1016/j.ijcard.2017.08.068. Epub 2017 Sep 8.

  PMID: 29031990 BACKGROUND

• Kunadian V, Chieffo A, Camici PG, Berry C, Escaned J, Maas AHEM, Prescott E, Karam N, Appelman Y, Fraccaro C, Louise Buchanan G, Manzo-Silberman S, Al-Lamee R, Regar E, Lansky A, Abbott JD, Badimon L, Duncker DJ, Mehran R, Capodanno D, Baumbach A. An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group. Eur Heart J. 2020 Oct 1;41(37):3504-3520. doi: 10.1093/eurheartj/ehaa503.

  PMID: 32626906 BACKGROUND

• Bigler MR, Seiler C. Detection of myocardial ischemia by intracoronary ECG using convolutional neural networks. PLoS One. 2021 Jun 14;16(6):e0253200. doi: 10.1371/journal.pone.0253200. eCollection 2021.

  PMID: 34125855 BACKGROUND

• 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.

  PMID: 38278503 DERIVED

• 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.

  PMID: 38011991 DERIVED

MeSH Terms

Conditions

Microvascular Angina; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Angina Pectoris; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 25, 2022
• Study Start: July 21, 2022
• Primary Completion: September 20, 2022
• Study Completion: October 15, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

TU (1)