An observational study in Acute Myocardial Infarction, Non-Obstructive Coronary Atherosclerosis and Ischemic Heart Disease, sponsored by AHEPA University Hospital. Completed at 3 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by AHEPA University Hospital · Observational
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.
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.
1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.
This study's enrollment of 60 is below the median of 318 across 398 observational studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →AHEPA University Hospital is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will enroll consecutive patients with MINOCA admitted to study clinical sites.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Prevalence, demographics, clinical profile, anginal status, presence of cardiovascular risk factors, management and outcomes
1. Complete normal coronary arteries 2. Diffuse non-obstructive coronary artery disease 3. Non-obstructive high-risk plaques 4. Myocardial bridges
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).
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Extent of coronary atherosclerosis
Total atherosclerotic plaque volume (mm3)
Time frame: 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/.
Time frame: 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).
Time frame: 15 days after the acute event
Indexed Coronary Volume
Calculated by dividing the total coronary volume to the left ventricle (LV) mass, both derived from CCTA (mm3/gr)
Time frame: 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.
Time frame: 12 months
Chest-pain rehospitalization
Frequency (%) of chest-pain rehospitalization
Time frame: 12 months
Hospitalization for a bleeding event
Frequency (%) of hospitalization for a bleeding event
Time frame: 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)
Time frame: 15 days after the acute event
Atrial Fibrillation
Frequency (%) of occurrence of atrial fibrillation
Time frame: 12 months
Heart Failure
Frequency (%) of occurrence of acute decompensated heart failure with or without cardiogenic shock
Time frame: 12 months
Plan to share: Undecided
Ran from Jan 2021 to primary completion in Jan 2024, 36 months.
Of 165 non-industry observational studies under Myocardial Ischemia, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 127. This study's 36 months is below that.
Counting every sponsor, half of 204 studies reached it within 40 months; a quarter within 21 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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AHEPA University Hospital