Acute Myocardial InfarctionMINOCA-GRNCT04186676

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

An observational study of Acute Myocardial Infarction and Non-Obstructive Coronary Atherosclerosis, run by AHEPA University Hospital at 3 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Myocardial Infarction, Non-Obstructive Coronary Atherosclerosis, Ischemic Heart Disease
What is being tested?: MINOCA registry and CCTA Phenotypes
How many people: 60 participants
Where: 3 sitesGreece
Study dates: 1 Jan 2021to 30 Jan 2024
How long will I take part?: 12 Months
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Greece3 sites

National & Kapodistrian University of Athens, First Department of Cardiology, Hippokration Hospital
Athens
AHEPA University Hospital
Thessaloniki, 54636
General Hospital of Veroia
Véroia, Imathia, 59132

Other trials in Greece

About this study

Official title: Myocardial Infarction With Non-Obstructive Coronary Arteries in the Greek Population: Diagnosis and Management (The MINOCA-GR Registry)

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.

Read the 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.

Conditions: Acute Myocardial Infarction, Non-Obstructive Coronary Atherosclerosis, Ischemic Heart Disease, Angina Pectoris, Coronary Microvascular Disease
Being tested: MINOCA registry, CCTA Phenotypes
Keywords: MINOCA, Myocardial Infarction, Cardiac Computed Tomography Angiography, Angina, Leiden CTA risk score, Indexed Coronary Volume
Medical subject headings: Myocardial Ischemia, Angina Pectoris, Microvascular Angina, MINOCA, Myocardial Infarction

What participants receive

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

MINOCA registryOther
Prevalence, demographics, clinical profile, anginal status, presence of cardiovascular risk factors, management and outcomes
CCTA PhenotypesDiagnostic test
1. Complete normal coronary arteries
2. Diffuse non-obstructive coronary artery disease
3. Non-obstructive high-risk plaques
4. Myocardial bridges

Study groups in NCT04186676
Study group	Role	What they receive
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 Receives: Other: MINOCA registry; Diagnostic Test: CCTA Phenotypes

What is being measured

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

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).
Measured: 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).
Measured: 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).
Measured: 12 months
Extent of coronary atherosclerosis
Total atherosclerotic plaque volume (mm3)
Measured: 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/.
Measured: 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).
Measured: 15 days after the acute event

Secondary outcomes (7)

Indexed Coronary Volume
Calculated by dividing the total coronary volume to the left ventricle (LV) mass, both derived from CCTA (mm3/gr)
Measured: 15 days after the acute event
Generic health status [Medical Outcomes Study 12-Item Short Form (SF-12)]
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.
Measured: 12 months
Chest-pain rehospitalization
Frequency (%) of chest-pain rehospitalization
Measured: 12 months
Hospitalization for a bleeding event
Frequency (%) of hospitalization for a bleeding event
Measured: 12 months
Frequency of occurrence of high-risk plaques
Frequency (%) of occurrence of high-risk plaque features (HU <30, remodelling index > 1.1, napkin-ring sign, spotty calcium)
Measured: 15 days after the acute event
Atrial Fibrillation
Frequency (%) of occurrence of atrial fibrillation
Measured: 12 months
Heart Failure
Frequency (%) of occurrence of acute decompensated heart failure with or without cardiogenic shock
Measured: 12 months

Timeline

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

1 Jan 202130 Jan 2024

First posted5 Dec 2019
Study start1 Jan 2021
Primary completion1 Jan 2024
Study completion30 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 only
Time perspective: Prospective
Enrolment: 60 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04186676
Sponsor's protocol ID: CIP_001_MINOCA_GR_27.11.2019
Acronym: MINOCA-GR
Status last verified: Jan 2024
First submitted: 29 Nov 2019
Last updated: 1 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 31104809
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.
PubMed 28158518
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.
PubMed 30153967
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.
PubMed 30913893
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.
PubMed 28239487
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.
PubMed 29311033
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.
PubMed 30367850
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.
PubMed 30660516
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.
PubMed 31894527
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.
PubMed 31974008
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.
PubMed 35110321

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Myocardial Infarction With Non-Obstructive Coronary Arteries in the Greek Population: Diagnosis and Management (The MINOCA-GR Registry)
ClinicalTrials.gov ID: NCT04186676
Acronym / sponsor ID: MINOCA-GR / CIP_001_MINOCA_GR_27.11.2019
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
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AHEPA University HospitalUniversity, hospital or other
Collaborators: New York University, University of Zurich
Study start: 1 Jan 2021 (actual)
Primary completion: 1 Jan 2024 (actual)
Study completion: 30 Jan 2024 (actual)
First posted: 5 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Regarding Greece, the MINOCA-GR registry will be the first prospectively enrolling medical database of this magnitude.

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 1

Arm	Type	Receives
MINOCA patients	–	Other: MINOCA registry, Diagnostic Test: CCTA PhenotypesPrevalence, 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study will enroll consecutive patients with MINOCA admitted to study clinical sites.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MINOCA registryPrevalence, demographics, clinical profile, anginal status, presence of cardiovascular risk factors, management and outcomes	Other	MINOCA patients
CCTA Phenotypes1. Complete normal coronary arteries 2. Diffuse non-obstructive coronary artery disease 3. Non-obstructive high-risk plaques 4. Myocardial bridges	Diagnostic test	MINOCA patients

Primary outcome

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).
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).
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).
Extent of coronary atherosclerosis
Time frame: 15 days after the acute event
Total atherosclerotic plaque volume (mm3)
Extent of coronary atherosclerosis using Leiden CTA risk score
Time frame: 15 days after the acute event
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/.
Extent of coronary atherosclerosis using Gensini score
Time frame: 15 days after the acute event
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).

7 secondary outcomes

Indexed Coronary Volume
Time frame: 15 days after the acute event
Generic health status [Medical Outcomes Study 12-Item Short Form (SF-12)]
Time frame: 12 months
Chest-pain rehospitalization
Time frame: 12 months
Hospitalization for a bleeding event
Time frame: 12 months
Frequency of occurrence of high-risk plaques
Time frame: 15 days after the acute event
Atrial Fibrillation
Time frame: 12 months
Heart Failure
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
Background: PubMed 31104809Rampidis 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.
Background: PubMed 28158518Agewall 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.
Background: PubMed 30153967Thygesen 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.
Background: PubMed 30913893Tamis-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.
Background: PubMed 28239487Grodzinsky 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.
Background: PubMed 29311033Ahmadi 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.
Background: PubMed 30367850Nordenskjold 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.
Background: PubMed 30660516van 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.
Background: PubMed 31894527Benetos 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.
Background: PubMed 31974008Benz 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.
Derived from this study: PubMed 35110321Rampidis 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Georgios Giannakoulas, MD, PhD principal investigator

AHEPA University Hospital of Thessaloniki

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction and Non-Obstructive Coronary Atherosclerosis, run by AHEPA University Hospital at 3 sites in Greece.

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Greece. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of post-MI angina [Seattle Angina Questionnaire (SAQ)] (time frame: 1 month). The study lists 6 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 NCT04186676, which also lists 11 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 Feb 2024.