NCT02769650

Brief Summary

The hypothesis of this study is that Stress-MRI is a clinically significant method of myocardial perfusion assessment after coronary angioplasty with stenting of right coronary artery (RCA) chronic total occlusion (CTO) is performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

3.5 years

First QC Date

May 8, 2016

Last Update Submit

May 15, 2016

Conditions

Ischemic Heart DiseaseCoronary AtherosclerosisCoronary Artery DiseaseCoronary Artery Stenosis

Keywords

Coronary stenosisDrug-eluting stentCoronary angioplasty with stentingIschemic Heart DiseaseChronic total occlusionRight coronary arteryStress-MRI

Outcome Measures

Primary Outcomes (1)

  • Stress-MRI evaluation

    High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)

    Within 2 and 12 month after hospitalization

Secondary Outcomes (3)

  • Clinical assessment

    Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization

  • Stress-MRI evaluation (2)

    Within 2 and 12 month after hospitalization

  • Major adverse cardiac and cerebrovascular events (MACCE)

    During 1 year after first stress-MRI assessment

Study Arms (2)

Stress-MRI + Chronic total occlusion PCI

EXPERIMENTAL

Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO

Procedure: CTO coronary angioplastyProcedure: Stress-MRI

Stress-MRI + Optimal medicamentous treatment

ACTIVE COMPARATOR

Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment

Drug: Optimal medicamentous treatmentProcedure: Stress-MRI

Interventions

CTO coronary angioplastyPROCEDURE

A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.

Stress-MRI + Chronic total occlusion PCI
Optimal medicamentous treatmentDRUG
Stress-MRI + Optimal medicamentous treatment
Stress-MRIPROCEDURE

A standard stress-MRI test with adenosine

Stress-MRI + Chronic total occlusion PCIStress-MRI + Optimal medicamentous treatment

Eligibility Criteria

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

You may qualify if:

  • Stable angina, CCS FC II-IV
  • "Right-dominance" coronary circulation according to coronary angiography
  • Absence of other significant atherosclerotic coronary lesions (more than 65%)
  • High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)
  • Signed, documented informed consent prior to admission to the study

You may not qualify if:

  • Acute coronary syndrome
  • Contraindications for adenosine stress test
  • Low and moderate risk of myocardium ischemia according to stress-MRI data (perfusion defect in less than 2 segments in the area of interest)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2016

First Posted

May 11, 2016

Study Start

October 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 17, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)