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

NCT ID: NCT02655718

Last Updated: 2016-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with ACS

Patients with ACS who underwent coronary angiography within 72 hours from the onset of disease. In identifying nonobstructive coronary atherosclerosis , patients underwent cardiac contrast MRI.

Group Type OTHER

Patients with ACS

Intervention Type OTHER

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

MRI

Intervention Type DEVICE

Interventions

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Patients with ACS

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

Intervention Type OTHER

MRI

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Russian Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Vyacheslav Ryabov

MD, PhD Research Institute for Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vyacheslav Ryabov, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute for Cardiology

Locations

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Research Institutite for Cardiology

Tomsk, Tomskii Region, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Vyacheslav Ryabov, MD,PhD

Role: CONTACT

+73822553689

Sayana Gomboeva, MD

Role: CONTACT

+73822558360

Facility Contacts

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Vyacheslav Ryabov, MD, Phd

Role: primary

+73822553689

Other Identifiers

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2411

Identifier Type: -

Identifier Source: org_study_id

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