Clinical trial NCT02655718: Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis
Official title: Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: ACS
Non obstructive coronary atherosclerosis
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to assess short and long term outcomes of acute coronary syndrome in patients with non obstructive coronary atherosclerosis, to optimize the algorithm for diagnosis and to evaluate its effectiveness

Detailed description: The study non randomized, opened, controlled. Cardiovascular Magnetic - resonance imaging reveals both ischemic and non-ischemic causes of acute coronary syndrome. Currently, it is the best method for Imaging and damage assessment of myocardial viability in coronary atherosclerosis and noncoronary injuries (V.Yu.Usov 2012).

Taking into account the results of previous (D. Kawecki, B. Morawiec, P. Monney, 2015) research, it can be concluded that the introduction of cardiovascular magnetic resonance imaging into routine practice will change the structure of morbidity among patients with acute coronary syndrome and non obstructive coronary atherosclerosis . The research was conducted on small groups of patients, and therefore further data acquisition is required.

It is planned to study 200 patients with acute coronary syndrome. On admission, they will receive the standard treatment of ACS with and without ST elevation. Within 72 hours they will performed diagnostic coronary angiography. If in case of non stenotic atherosclerosis of coronary artery (normal / stenosis \< 50%) patients are planned for cardiac contrast MRI, which will identify both ischemic and non-ischemic causes of acute coronary syndrome. At 30 days, 6 months, 12 months the researchers will assess the clinical condition of the patients, perform cardiac ultrasound for the evaluation of myocardial contractile function, evaluate the incidence rate of secondary endpoints

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years at time of randomization (18 years and older)
* acute coronary syndrome
* no obstructive coronary atherosclerosis (normal coronary artety/ plaques \<50%) is based on the results of coronary angiography for 3 days of admission
* written the informed consent to participate in research

Exclusion Criteria:

* patients previously undergone endovascular / surgical revascularization of coronary artery
* severe comorbidity
* Contacts/Locations

Primary outcomes:
measure: Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue
timeFrame: 14 days after ACS
measure: Left ventricular ejection fraction (Echo)
timeFrame: 14 days after ACS
Secondary outcomes:
measure: Incidence of the acute myocardial infarction
timeFrame: 14 days after ACS
measure: Incidence of unstable angina
timeFrame: 14 days after ACS
measure: Incidence of Takotsubo syndrome
timeFrame: 14 days after ACS
measure: Incidence of myocarditis
timeFrame: 14 days after ACS
measure: Incidence of the mortality
timeFrame: 6 month and 12 month after ACS
measure: Incidence of the recurrent myocardial infarction
timeFrame: 6 month and 12 month after ACS
measure: Incidence of the heart failure
timeFrame: 6 month and 12 month after ACS
measure: Incidence of the stroke
timeFrame: 6 month and 12 month after ACS
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Research Institutite for Cardiology
state: Tomskii region
Study officials:
affiliation: Research Institute for Cardiology
name: Vyacheslav Ryabov, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: