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

Acute Coronary Syndrome Clinical Trial

— NOCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02655718
• Other study ID #: 2411
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2015
• Last updated: January 13, 2016
• Start date: October 2015
• Est. completion date: September 2018

Study information

• Verified date: January 2016
• Source: Russian Academy of Medical Sciences
• Contact: Vyacheslav Ryabov, MD,PhD
• Phone: +73822553689
• Email: rvvt[@]cardio-tomsk.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis
• Coronary Artery Disease
• Myocardial Ischemia
• Syndrome

Intervention

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.

Device:
• MRI

Locations

Country	Name	City	State
Russian Federation	Research Institutite for Cardiology	Tomsk	Tomskii region

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue		14 days after ACS	No
Primary	Left ventricular ejection fraction (Echo)		14 days after ACS	No
Secondary	Incidence of the acute myocardial infarction		14 days after ACS	No
Secondary	Incidence of unstable angina		14 days after ACS	No
Secondary	Incidence of Takotsubo syndrome		14 days after ACS	No
Secondary	Incidence of myocarditis		14 days after ACS	No
Secondary	Incidence of the mortality		6 month and 12 month after ACS	No
Secondary	Incidence of the recurrent myocardial infarction		6 month and 12 month after ACS	No
Secondary	Incidence of the heart failure		6 month and 12 month after ACS	No
Secondary	Incidence of the stroke		6 month and 12 month after ACS	No