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

Primary Purpose

Acute Coronary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Patients with ACS
MRI
Sponsored by
Russian Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring ACS, Non obstructive coronary atherosclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Institutite for CardiologyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with ACS

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue
Left ventricular ejection fraction (Echo)

Secondary Outcome Measures

Incidence of the acute myocardial infarction
Incidence of unstable angina
Incidence of Takotsubo syndrome
Incidence of myocarditis
Incidence of the mortality
Incidence of the recurrent myocardial infarction
Incidence of the heart failure
Incidence of the stroke

Full Information

First Posted
December 29, 2015
Last Updated
January 13, 2016
Sponsor
Russian Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02655718
Brief Title
Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis
Acronym
NOCA
Official Title
Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
ACS, Non obstructive coronary atherosclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with ACS
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Patients with ACS
Intervention Description
Cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images.
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue
Time Frame
14 days after ACS
Title
Left ventricular ejection fraction (Echo)
Time Frame
14 days after ACS
Secondary Outcome Measure Information:
Title
Incidence of the acute myocardial infarction
Time Frame
14 days after ACS
Title
Incidence of unstable angina
Time Frame
14 days after ACS
Title
Incidence of Takotsubo syndrome
Time Frame
14 days after ACS
Title
Incidence of myocarditis
Time Frame
14 days after ACS
Title
Incidence of the mortality
Time Frame
6 month and 12 month after ACS
Title
Incidence of the recurrent myocardial infarction
Time Frame
6 month and 12 month after ACS
Title
Incidence of the heart failure
Time Frame
6 month and 12 month after ACS
Title
Incidence of the stroke
Time Frame
6 month and 12 month after ACS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vyacheslav Ryabov, MD,PhD
Phone
+73822553689
Email
rvvt@cardio-tomsk.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Sayana Gomboeva, MD
Phone
+73822558360
Email
gomboevasayana@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD,PhD
Organizational Affiliation
Research Institute for Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institutite for Cardiology
City
Tomsk
State/Province
Tomskii region
ZIP/Postal Code
634012
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, Phd
Phone
+73822553689
Email
rvvt@cardio-tomsk.ru
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, PhD

12. IPD Sharing Statement

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

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