NCT02655718

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

2.9 years

First QC Date

December 29, 2015

Last Update Submit

January 13, 2016

Conditions

Keywords

ACSNon obstructive coronary atherosclerosis

Outcome Measures

Primary Outcomes (2)

  • Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue

    14 days after ACS

  • Left ventricular ejection fraction (Echo)

    14 days after ACS

Secondary Outcomes (8)

  • Incidence of the acute myocardial infarction

    14 days after ACS

  • Incidence of unstable angina

    14 days after ACS

  • Incidence of Takotsubo syndrome

    14 days after ACS

  • Incidence of myocarditis

    14 days after ACS

  • Incidence of the mortality

    6 month and 12 month after ACS

  • +3 more secondary outcomes

Study Arms (1)

Patients with ACS

OTHER

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.

Other: Patients with ACSDevice: MRI

Interventions

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

Patients with ACS
MRIDEVICE
Patients with ACS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients previously undergone endovascular / surgical revascularization of coronary artery
  • severe comorbidity
  • Contacts/Locations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institutite for Cardiology

Tomsk, Tomskii Region, 634012, Russia

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Vyacheslav Ryabov, MD,PhD

    Research Institute for Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vyacheslav Ryabov, MD,PhD

CONTACT

Sayana Gomboeva, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Research Institute for Cardiology

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 14, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations