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

January 13, 2016 updated by: Vyacheslav Ryabov, Russian Academy of Medical Sciences
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Tomskii region
      • Tomsk, Tomskii region, Russian Federation, 634012
        • Recruiting
        • Research Institutite for Cardiology
        • Contact:
        • Principal Investigator:
          • Vyacheslav Ryabov, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: MRI
Other: Patients with ACS
Cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue
Time Frame: 14 days after ACS
14 days after ACS
Left ventricular ejection fraction (Echo)
Time Frame: 14 days after ACS
14 days after ACS

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of the acute myocardial infarction
Time Frame: 14 days after ACS
14 days after ACS
Incidence of unstable angina
Time Frame: 14 days after ACS
14 days after ACS
Incidence of Takotsubo syndrome
Time Frame: 14 days after ACS
14 days after ACS
Incidence of myocarditis
Time Frame: 14 days after ACS
14 days after ACS
Incidence of the mortality
Time Frame: 6 month and 12 month after ACS
6 month and 12 month after ACS
Incidence of the recurrent myocardial infarction
Time Frame: 6 month and 12 month after ACS
6 month and 12 month after ACS
Incidence of the heart failure
Time Frame: 6 month and 12 month after ACS
6 month and 12 month after ACS
Incidence of the stroke
Time Frame: 6 month and 12 month after ACS
6 month and 12 month after ACS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Russian Academy of Medical Sciences

Investigators

  • Principal Investigator: Vyacheslav Ryabov, MD,PhD, Research Institute for Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

December 29, 2015

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 14, 2016

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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