Myocardial Infarction With Non-Obstructive Coronary Arteries in the Greek Population

NCT04186676 | Completed

• 1 other identifier: CIP_001_MINOCA_GR_27.11.2019
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The MINOCA-GR registry will be the first nationwide study aiming to obtain data regarding prevalence, demographics, clinical profile, previous anginal status, presence of cardiovascular risk factors, management and outcomes in patients with Myocardial Infarction with Non-Obstructive Coronary Arteries. An additional purpose of the registry is to highlight, for the first time worldwide to the best of the investigator's knowledge, the role of cardiac computed tomography angiography for risk stratification and personalized therapeutic approach in MINOCA patients.

Conditions

Acute Myocardial Infarction; Non-Obstructive Coronary Atherosclerosis; Ischemic Heart Disease; Angina Pectoris; Coronary Microvascular Disease

Keywords

MINOCA; Myocardial Infarction; Cardiac Computed Tomography Angiography; Angina; Leiden CTA risk score; Indexed Coronary Volume

Outcome Measures

Primary Outcomes (6)

• Frequency of post-MI angina [Seattle Angina Questionnaire (SAQ)]

  The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life).

  1 month

• Frequency of post-MI angina [Seattle Angina Questionnaire (SAQ)]

  The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life).

  6 months

• Frequency of post-MI angina [Seattle Angina Questionnaire (SAQ)]

  The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life).

  12 months

• Extent of coronary atherosclerosis

  Total atherosclerotic plaque volume (mm3)

  15 days after the acute event

• Extent of coronary atherosclerosis using Leiden CTA risk score

  Leiden CTA risk score incorporates the presence, extent, severity, location, and composition of coronary artery disease (CAD). Leiden CTA score is calculated using the following approach. First, the presence of CAD is determined in each segment. When plaque is absent the score is 0. When plaque is present a score of 1.1, 1.2 or 1.3 is given according to plaque composition (calcified, noncalcified, and mixed plaque, respectively). Subsequently, this score is multiplied by a weight factor for the location of the segment in the coronary artery tree (0.5 through 6 according to vessel, proximal location and system dominance) and multiplied by a weight factor for stenosis severity (1.4 for ≥50% stenosis and 1.0 for stenosis \<50%). The final score (range 0 to 42) is calculated by addition of the individual segment scores. Leiden CTA risk score calculator is available at: http://18.224.14.19/calcApp/.

  15 days after the acute event

• Extent of coronary atherosclerosis using Gensini score

  The relative severity of a lesion is indicated using a score of 1 for 1-25% obstruction and doubling that number as the severity of obstruction progresses with each step in the 25-50-75-90-99-100% diameter reduction. Thus, the severity score for each lesion may range from 1 to 32. Furthermore, the score weighed according to the usual blood flow to the left ventricle in each vessel or vessel segment. A multiplying factor is applied to each lesion score based upon its location in the coronary tree, depending on the functional significance of the area supplied by that segment. If a segment is totally occluded or 99% stenosed and receiving collaterals, a collateral adjustment factor is used, and the adjustment is reduced by the extent of disease in the vessel that is the source of collaterals. The final score is the sum of all the lesion scores (Reference: Rampidis GP et al. A guide for Gensini Score calculation. Atherosclerosis 2019 August 2019;287:181-183).

  15 days after the acute event

Secondary Outcomes (7)

• Indexed Coronary Volume

  15 days after the acute event

• Generic health status [Medical Outcomes Study 12-Item Short Form (SF-12)]

  12 months

• Chest-pain rehospitalization

  12 months

• Hospitalization for a bleeding event

  12 months

• Frequency of occurrence of high-risk plaques

  15 days after the acute event

Study Arms (1)

MINOCA patients

Prevalence, demographics, clinical profile, previous anginal status, presence of cardiovascular risk factors, management and outcomes in consecutive patients with Myocardial Infarction with Non-Obstructive Coronary Arteries admitted to study clinical sites

Other: MINOCA registry; Diagnostic Test: CCTA Phenotypes

Interventions

MINOCA registry OTHER

Prevalence, demographics, clinical profile, anginal status, presence of cardiovascular risk factors, management and outcomes

MINOCA patients

CCTA Phenotypes DIAGNOSTIC_TEST

1. Complete normal coronary arteries 2. Diffuse non-obstructive coronary artery disease 3. Non-obstructive high-risk plaques 4. Myocardial bridges

MINOCA patients

Eligibility Criteria

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

Study Population

This study will enroll consecutive patients with MINOCA admitted to study clinical sites.

You may qualify if:

• Patients older than 18 years
• Patients without known history of coronary artery disease
• Patients with acute coronary syndrome with and/or without ST-segment elevation who underwent coronary angiography within 24h after onset of the disease
• Absence of obstructive coronary atherosclerosis (normal coronary arteries or plaques \<50% stenosis) based on the results of invasive coronary angiography
• Subject has provided written informed consent
• Subject is willing to comply with study follow-up requirements

You may not qualify if:

• Patients \< 18 years old at time of coronary angiography
• Patients with a previous history of coronary artery disease and/or prior revascularization
• Patients with serious concurrent disease and life expectancy of \< 1 year
• Patients who refuse to give written consent for participation in the study
• In the investigator's opinion, subject will not be able to comply with the follow-up requirements
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the study
• Subject has a known allergy to contrast agent that cannot be adequately pre-medicated

Sponsors & Collaborators

• AHEPA University Hospital: lead
• New York University: collaborator
• University of Zurich: collaborator

Study Sites (3)

General Hospital of Veroia

Véroia, Imathia, 59132, Greece

Location

National & Kapodistrian University of Athens, First Department of Cardiology, Hippokration Hospital

Athens, Greece

Location

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (11)

• Rampidis GP, Benetos G, Benz DC, Giannopoulos AA, Buechel RR. A guide for Gensini Score calculation. Atherosclerosis. 2019 Aug;287:181-183. doi: 10.1016/j.atherosclerosis.2019.05.012. Epub 2019 May 10. No abstract available.

  PMID: 31104809 BACKGROUND

• Agewall S, Beltrame JF, Reynolds HR, Niessner A, Rosano G, Caforio AL, De Caterina R, Zimarino M, Roffi M, Kjeldsen K, Atar D, Kaski JC, Sechtem U, Tornvall P; WG on Cardiovascular Pharmacotherapy. ESC working group position paper on myocardial infarction with non-obstructive coronary arteries. Eur Heart J. 2017 Jan 14;38(3):143-153. doi: 10.1093/eurheartj/ehw149. No abstract available.

  PMID: 28158518 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.

  PMID: 30153967 BACKGROUND

• Tamis-Holland JE, Jneid H, Reynolds HR, Agewall S, Brilakis ES, Brown TM, Lerman A, Cushman M, Kumbhani DJ, Arslanian-Engoren C, Bolger AF, Beltrame JF; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; and Council on Quality of Care and Outcomes Research. Contemporary Diagnosis and Management of Patients With Myocardial Infarction in the Absence of Obstructive Coronary Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Apr 30;139(18):e891-e908. doi: 10.1161/CIR.0000000000000670.

  PMID: 30913893 BACKGROUND

• Grodzinsky A, Arnold SV, Gosch K, Spertus JA, Foody JM, Beltrame J, Maddox TM, Parashar S, Kosiborod M. Angina Frequency After Acute Myocardial Infarction In Patients Without Obstructive Coronary Artery Disease. Eur Heart J Qual Care Clin Outcomes. 2015;1(2):92-99. doi: 10.1093/ehjqcco/qcv014. Epub 2015 Jul 23.

  PMID: 28239487 BACKGROUND

• Ahmadi A, Leipsic J, Ovrehus KA, Gaur S, Bagiella E, Ko B, Dey D, LaRocca G, Jensen JM, Botker HE, Achenbach S, De Bruyne B, Norgaard BL, Narula J. Lesion-Specific and Vessel-Related Determinants of Fractional Flow Reserve Beyond Coronary Artery Stenosis. JACC Cardiovasc Imaging. 2018 Apr;11(4):521-530. doi: 10.1016/j.jcmg.2017.11.020. Epub 2018 Jan 5.

  PMID: 29311033 BACKGROUND

• Nordenskjold AM, Lagerqvist B, Baron T, Jernberg T, Hadziosmanovic N, Reynolds HR, Tornvall P, Lindahl B. Reinfarction in Patients with Myocardial Infarction with Nonobstructive Coronary Arteries (MINOCA): Coronary Findings and Prognosis. Am J Med. 2019 Mar;132(3):335-346. doi: 10.1016/j.amjmed.2018.10.007. Epub 2018 Oct 25.

  PMID: 30367850 BACKGROUND

• van Rosendael AR, Shaw LJ, Xie JX, Dimitriu-Leen AC, Smit JM, Scholte AJ, van Werkhoven JM, Callister TQ, DeLago A, Berman DS, Hadamitzky M, Hausleiter J, Al-Mallah MH, Budoff MJ, Kaufmann PA, Raff G, Chinnaiyan K, Cademartiri F, Maffei E, Villines TC, Kim YJ, Feuchtner G, Lin FY, Jones EC, Pontone G, Andreini D, Marques H, Rubinshtein R, Achenbach S, Dunning A, Gomez M, Hindoyan N, Gransar H, Leipsic J, Narula J, Min JK, Bax JJ. Superior Risk Stratification With Coronary Computed Tomography Angiography Using a Comprehensive Atherosclerotic Risk Score. JACC Cardiovasc Imaging. 2019 Oct;12(10):1987-1997. doi: 10.1016/j.jcmg.2018.10.024. Epub 2019 Jan 16.

  PMID: 30660516 BACKGROUND

• Benetos G, Buechel RR, Goncalves M, Benz DC, von Felten E, Rampidis GP, Clerc OF, Messerli M, Giannopoulos AA, Gebhard C, Fuchs TA, Pazhenkottil AP, Kaufmann PA, Grani C. Coronary artery volume index: a novel CCTA-derived predictor for cardiovascular events. Int J Cardiovasc Imaging. 2020 Apr;36(4):713-722. doi: 10.1007/s10554-019-01750-2. Epub 2020 Jan 1.

  PMID: 31894527 BACKGROUND

• Benz DC, Benetos G, Rampidis G, von Felten E, Bakula A, Sustar A, Kudura K, Messerli M, Fuchs TA, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Validation of deep-learning image reconstruction for coronary computed tomography angiography: Impact on noise, image quality and diagnostic accuracy. J Cardiovasc Comput Tomogr. 2020 Sep-Oct;14(5):444-451. doi: 10.1016/j.jcct.2020.01.002. Epub 2020 Jan 13.

  PMID: 31974008 BACKGROUND

• Rampidis GP, Kampaktsis PNu, Kouskouras K, Samaras A, Benetos G, Giannopoulos AAlpha, Karamitsos T, Kallifatidis A, Samaras A, Vogiatzis I, Hadjimiltiades S, Ziakas A, Buechel RR, Gebhard C, Smilowitz NR, Toutouzas K, Tsioufis K, Prassopoulos P, Karvounis H, Reynolds H, Giannakoulas G. Role of cardiac CT in the diagnostic evaluation and risk stratification of patients with myocardial infarction and non-obstructive coronary arteries (MINOCA): rationale and design of the MINOCA-GR study. BMJ Open. 2022 Feb 2;12(2):e054698. doi: 10.1136/bmjopen-2021-054698.

  PMID: 35110321 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Angina Pectoris; Microvascular Angina; MINOCA; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Georgios Giannakoulas, MD, PhD

  AHEPA University Hospital of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 5, 2019
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 30, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

GR (3)