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

Completed

• Conditions: Ischemic Heart Disease; Coronary Microvascular Disease; Acute Myocardial Infarction; Non-Obstructive Coronary Atherosclerosis; Angina Pectoris
• Interventions: Other: MINOCA registry; Diagnostic Test: CCTA Phenotypes

• Registration Number: NCT04186676
• Lead Sponsor: AHEPA University Hospital

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.

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 Timeline

• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-05
• Study Start: 2021-01-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-30
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MINOCA patients	MINOCA registry	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
MINOCA patients	CCTA Phenotypes	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

Primary Outcome Measures

Name	Time	Method
Frequency of post-MI angina [Seattle Angina Questionnaire (SAQ)]	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	15 days after the acute event	Total atherosclerotic plaque volume (mm3)
Extent of coronary atherosclerosis using Leiden CTA risk score	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	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).

Secondary Outcome Measures

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

Trial Locations

Locations (3)

General Hospital of Veroia; 🇬🇷 Véroia, Imathia, Greece

National & Kapodistrian University of Athens, First Department of Cardiology, Hippokration Hospital; 🇬🇷 Athens, Greece

AHEPA University Hospital; 🇬🇷 Thessaloníki, Greece