- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02655718
Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis (NOCA)
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vyacheslav Ryabov, MD,PhD
- Phone Number: +73822553689
- Email: rvvt@cardio-tomsk.ru
Study Contact Backup
- Name: Sayana Gomboeva, MD
- Phone Number: +73822558360
- Email: gomboevasayana@gmail.com
Study Locations
-
-
Tomskii region
-
Tomsk, Tomskii region, Russian Federation, 634012
- Recruiting
- Research Institutite for Cardiology
-
Contact:
- Vyacheslav Ryabov, MD, Phd
- Phone Number: +73822553689
- Email: rvvt@cardio-tomsk.ru
-
Principal Investigator:
- Vyacheslav Ryabov, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
Investigators
- Principal Investigator: Vyacheslav Ryabov, MD,PhD, Research Institute for Cardiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
Clinical Trials on Acute Coronary Syndrome
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
Meditrix CorpNational University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health UniversityRecruitingChronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeJapan, Ireland
-
OrbusNeichDuke Clinical Research Institute; OrbusNeich Medical K.K.CompletedCoronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary SyndromeUnited States, Japan
-
Medical University of WarsawRecruitingAcute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromePoland
-
Niguarda HospitalCompletedAcute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic AneurysmsItaly
-
Sohag UniversityRecruitingLeft Main Coronary Artery Disease With Acute Coronary SyndromeEgypt
-
Eli Lilly and CompanyDaiichi Sankyo, Inc.CompletedCoronary Arteriosclerosis | Acute Coronary SyndromesUnited States
-
University of PatrasCompletedCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)Greece
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Yonsei UniversityCompletedAcute Coronary Syndrome (ACS)Korea, Republic of
Clinical Trials on MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Assistance Publique Hopitaux De MarseilleActive, not recruitingMultiple SclerosisFrance
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States
-
Abbott Medical DevicesCompletedAdverse Effect of MRI on an Implanted Pacemaker Lead | Adverse Effect of MRI on an Implanted PacemakerUnited States, Netherlands, Australia, Belgium, Finland
-
University of EdinburghActive, not recruiting
-
Assistance Publique - Hôpitaux de ParisUnknownBrain Injury, Coma | Cardiac Arrest (CA) | Traumatic Brain Injury (TBI) | Aneurysmal Subarachnoid Hemorrhages (aSAH)France
-
Sheba Medical CenterUnknown
-
University of ZurichBalgrist University HospitalNot yet recruiting