Ischemic Heart DiseaseNCT02769650
Stress-MRI Assessment After Right Coronary Artery CTO Recanalization
A study testing CTO coronary angioplasty, Optimal medicamentous treatment and Stress-MRI in people with Ischemic Heart Disease and Coronary Atherosclerosis, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease
- What is being tested?
- CTO coronary angioplasty, Optimal medicamentous treatment and Stress-MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2010to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of CIrculation Pathology
Novosibirsk, 630055
About this study
Official title: Clinical Significance of Stress-MRI Evaluation of Right Coronary Artery Chronic Total Occlusion Recanalization Efficacy in Patients With Coronary Artery Disease.
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.
- Conditions
- Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis
- Being tested
- CTO coronary angioplasty, Optimal medicamentous treatment, Stress-MRI
- Keywords
- Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Right coronary artery, Stress-MRI
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO coronary angioplastyProcedure or surgery
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.
Optimal medicamentous treatmentDrug
Stress-MRIProcedure or surgery
A standard stress-MRI test with adenosine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: CTO coronary angioplasty; Procedure: Stress-MRI |
| Stress-MRI + Optimal medicamentous treatment | Active comparator | Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment Receives: Drug: Optimal medicamentous treatment; Procedure: Stress-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 2 and 12 month after hospitalization
Secondary outcomes (3)
Clinical assessment
Dynamical assessment of stable angina FC (CCS) and dyspnea FC (NYHA)
Measured: Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization
Stress-MRI evaluation (2)
Dynamics of perfusion in myocardium scar tissue according to stress-MRI data
Measured: Within 2 and 12 month after hospitalization
Major adverse cardiac and cerebrovascular events (MACCE)
Major adverse cardiac and cerebrovascular events (MACCE) including: All-cause mortality, Myocardial infarction, Stroke, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.
Measured: During 1 year after first stress-MRI assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startOct 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769650
- Sponsor's protocol ID
- Stress-MRI 1.0
- Status last verified
- May 2016
- First submitted
- 8 May 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Stress-MRI Evaluation of Right Coronary Artery Chronic Total Occlusion Recanalization Efficacy in Patients With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT02769650
- Acronym / sponsor ID
- Stress-MRI 1.0
- Conditions
- Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis
- Keywords
- Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease, Chronic total occlusion, Right coronary artery, Stress-MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Oct 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress-MRI + Chronic total occlusion PCI | Experimental | Procedure: CTO coronary angioplasty, Procedure: Stress-MRIPre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO |
| Stress-MRI + Optimal medicamentous treatment | Active comparator | Drug: Optimal medicamentous treatment, Procedure: Stress-MRIPre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTO coronary angioplastyA 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. | Procedure or surgery | Stress-MRI + Chronic total occlusion PCI |
| Optimal medicamentous treatment | Drug | Stress-MRI + Optimal medicamentous treatment |
| Stress-MRIA standard stress-MRI test with adenosine | Procedure or surgery | Stress-MRI + Chronic total occlusion PCI, Stress-MRI + Optimal medicamentous treatment |
Primary outcome
Stress-MRI evaluation
Time frame: Within 2 and 12 month after hospitalization
High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)
3 secondary outcomes
Clinical assessment
Time frame: Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization
Stress-MRI evaluation (2)
Time frame: Within 2 and 12 month after hospitalization
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: During 1 year after first stress-MRI assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTO coronary angioplasty, Optimal medicamentous treatment and Stress-MRI in people with Ischemic Heart Disease and Coronary Atherosclerosis, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress-MRI evaluation (time frame: Within 2 and 12 month after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.