- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04186676
Myocardial Infarction With Non-Obstructive Coronary Arteries in the Greek Population (MINOCA-GR)
Myocardial Infarction With Non-Obstructive Coronary Arteries in the Greek Population: Diagnosis and Management (The MINOCA-GR Registry)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
MINOCA occurs in 5%-10% of all patients with Acute Myocardial Infarction (AMI) and these patients are younger and more often women in comparison with patients with AMI and obstructive Coronary Artery Disease (CAD). The underlying pathophysiological mechanisms are poorly understood, although several different mechanisms have been proposed, including plaque disruption, spasm, thromboembolism, dissection, microvascular dysfunction and ischemic myocardial injury attributable to supply/demand mismatch. In most, but not all, studies of prognosis, MINOCA patients had better outcomes than their AMI counterparts with coronary artery disease but faced a high risk for recurrent events, with one study finding that 25% of patients with MINOCA experience angina in the following year. Optimal patient management requires early diagnosis as well as understanding which of the myriad of mechanisms (atherosclerotic or non-atherosclerotic as well as a combination of both) may be underlying the initial diagnosis. The effects of secondary preventive treatments proven beneficial in patients with classical type I AMI are unknown in MINOCA patients; randomized clinical trials, and large observational studies, as well, evaluating different treatments in MINOCA patients do not exist. Hence, evidence-based guidelines for treatment of MINOCA are lacking. Elucidating the associations between different treatments and outcome may also increase the understanding of underlying mechanisms of MINOCA. The underlying mechanisms strongly determine prognosis and more importantly, therapeutic interventions as well as their success.
Likewise, multimodality imaging could provide new insights into the management of MINOCA patients. The current research reveals the utility of Cardiac Magnetic Resonance for diagnosis and risk stratification of suspected MINOCA patients but at the same time shows how much more information is needed to further characterize risk and ultimately develop therapeutic approaches to alter its natural history. Computed tomography has a suite of strengths including diagnosis of CAD, identification of plaque characteristics, morphology and perfusion data, and even possibly delayed enhancement; its ability to detect nonobstructive coronary disease by way of visualizing not only the lumen but also plaques is very helpful in our efforts trying to understand microvascular disease, plaque erosion, and myocardial infarction with no obstructive coronary artery. Furthermore, up until recently, high-risk plaque features and lesion specific ischemia are thought to be not directly related. However, emerging evidence suggests a possible relationship between high-risk plaque features, particularly low attenuation plaque volume and positive remodeling, with lesion specific ischemia by fractional flow reserve. Such relationship is independent of degree of luminal stenosis. As a result of the above, it is obvious that Cardiac Computed Tomography Angiography (CCTA) may have a potential role in some selected patients with MINOCA, depending on their clinical picture and stability.
Regarding Greece, the MINOCA-GR registry will be the first prospectively enrolling medical database of this magnitude.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Athens, Greece
- National & Kapodistrian University of Athens, First Department of Cardiology, Hippokration Hospital
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Thessaloníki, Greece, 54636
- Ahepa University Hospital
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Imathia
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Véroia, Imathia, Greece, 59132
- General Hospital of Veroia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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Prevalence, demographics, clinical profile, anginal status, presence of cardiovascular risk factors, management and outcomes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of post-MI angina [Seattle Angina Questionnaire (SAQ)]
Time Frame: 1 month
|
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).
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1 month
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Frequency of post-MI angina [Seattle Angina Questionnaire (SAQ)]
Time Frame: 6 months
|
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)]
Time Frame: 12 months
|
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).
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12 months
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Extent of coronary atherosclerosis
Time Frame: 15 days after the acute event
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Total atherosclerotic plaque volume (mm3)
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15 days after the acute event
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Extent of coronary atherosclerosis using Leiden CTA risk score
Time Frame: 15 days after the acute event
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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/.
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15 days after the acute event
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Extent of coronary atherosclerosis using Gensini score
Time Frame: 15 days after the acute event
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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).
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15 days after the acute event
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Indexed Coronary Volume
Time Frame: 15 days after the acute event
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Calculated by dividing the total coronary volume to the left ventricle (LV) mass, both derived from CCTA (mm3/gr)
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15 days after the acute event
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Generic health status [Medical Outcomes Study 12-Item Short Form (SF-12)]
Time Frame: 12 months
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The Medical Outcomes Study 12-Item Short Form (SF-12) is a general health questionnaire and is computed using the scores of 12 questions ranging from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.
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12 months
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Chest-pain rehospitalization
Time Frame: 12 months
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Frequency (%) of chest-pain rehospitalization
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12 months
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Hospitalization for a bleeding event
Time Frame: 12 months
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Frequency (%) of hospitalization for a bleeding event
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12 months
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Frequency of occurrence of high-risk plaques
Time Frame: 15 days after the acute event
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Frequency (%) of occurrence of high-risk plaque features (HU <30, remodelling index > 1.1, napkin-ring sign, spotty calcium)
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15 days after the acute event
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Atrial Fibrillation
Time Frame: 12 months
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Frequency (%) of occurrence of atrial fibrillation
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12 months
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Heart Failure
Time Frame: 12 months
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Frequency (%) of occurrence of acute decompensated heart failure with or without cardiogenic shock
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Georgios Giannakoulas, MD, PhD, AHEPA University Hospital of Thessaloniki
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Coronary Disease
- Chest Pain
- Myocardial Infarction
- Infarction
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Atherosclerosis
- Angina Pectoris
- Microvascular Angina
- MINOCA
Other Study ID Numbers
- CIP_001_MINOCA_GR_27.11.2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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