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Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis

Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02655718
Acronym
NOCA
Enrollment
200
Registered
2016-01-14
Start date
2015-10-31
Completion date
2018-09-30
Last updated
2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

ACS, Non obstructive coronary atherosclerosis

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

Interventions

OTHERPatients with ACS

Cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images.

DEVICEMRI

Sponsors

Russian Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue14 days after ACS
Left ventricular ejection fraction (Echo)14 days after ACS

Secondary

MeasureTime frame
Incidence of myocarditis14 days after ACS
Incidence of the mortality6 month and 12 month after ACS
Incidence of the recurrent myocardial infarction6 month and 12 month after ACS
Incidence of unstable angina14 days after ACS
Incidence of the stroke6 month and 12 month after ACS
Incidence of the acute myocardial infarction14 days after ACS
Incidence of the heart failure6 month and 12 month after ACS
Incidence of Takotsubo syndrome14 days after ACS

Countries

Russia

Contacts

Primary ContactVyacheslav Ryabov, MD,PhD
rvvt@cardio-tomsk.ru+73822553689
Backup ContactSayana Gomboeva, MD
gomboevasayana@gmail.com+73822558360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026