Acute Coronary SyndromeNOCANCT02655718
Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis
A study testing Patients with ACS and MRI in people with Acute Coronary Syndrome, run by Russian Academy of Medical Sciences at 1 site in Russia.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Patients with ACS and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2015to Sep 2018
- 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
- 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
Who cannot join
- patients previously undergone endovascular / surgical revascularization of coronary artery
- severe comorbidity
- Contacts/Locations
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Research Institutite for Cardiology
Tomsk, Tomskii Region, 634012
Vyacheslav Ryabov, MD, Phd, +73822553689, rvvt@cardio-tomsk.ru
Vyacheslav Ryabov, MD, PhD
About this study
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
Read the 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
- Conditions
- Acute Coronary Syndrome
- Being tested
- Patients with ACS, MRI
- Keywords
- ACS, Non obstructive coronary atherosclerosis
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with ACSOther
Cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images.
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patients with ACS; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue
Measured: 14 days after ACS
Left ventricular ejection fraction (Echo)
Measured: 14 days after ACS
Secondary outcomes (8)
Incidence of the acute myocardial infarction
Measured: 14 days after ACS
Incidence of unstable angina
Measured: 14 days after ACS
Incidence of Takotsubo syndrome
Measured: 14 days after ACS
Incidence of myocarditis
Measured: 14 days after ACS
Incidence of the mortality
Measured: 6 month and 12 month after ACS
Incidence of the recurrent myocardial infarction
Measured: 6 month and 12 month after ACS
Incidence of the heart failure
Measured: 6 month and 12 month after ACS
Incidence of the stroke
Measured: 6 month and 12 month after ACS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vyacheslav Ryabov, Russian Academy of Medical Sciences
- Investigators
- Vyacheslav Ryabov, MD,PhD, Principal investigator, Research Institute for Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655718
- Sponsor's protocol ID
- 2411
- Acronym
- NOCA
- Status last verified
- Jan 2016
- First submitted
- 29 Dec 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis
- ClinicalTrials.gov ID
- NCT02655718
- Acronym / sponsor ID
- NOCA / 2411
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, Non obstructive coronary atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 14 Jan 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 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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ACS | Other | Other: Patients with ACS, Device: MRIPatients with ACS who underwent coronary angiography within 72 hours from the onset of disease. In identifying nonobstructive coronary atherosclerosis , patients underwent cardiac contrast MRI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patients previously undergone endovascular / surgical revascularization of coronary artery
- severe comorbidity
- Contacts/Locations
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 |
|---|---|---|
| Patients with ACSCardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images. | Other | Patients with ACS |
| MRI | Device | Patients with ACS |
Primary outcome
Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue
Time frame: 14 days after ACS
Left ventricular ejection fraction (Echo)
Time frame: 14 days after ACS
8 secondary outcomes
Incidence of the acute myocardial infarction
Time frame: 14 days after ACS
Incidence of unstable angina
Time frame: 14 days after ACS
Incidence of Takotsubo syndrome
Time frame: 14 days after ACS
Incidence of myocarditis
Time frame: 14 days after ACS
Incidence of the mortality
Time frame: 6 month and 12 month after ACS
Incidence of the recurrent myocardial infarction
Time frame: 6 month and 12 month after ACS
Incidence of the heart failure
Time frame: 6 month and 12 month after ACS
Incidence of the stroke
Time frame: 6 month and 12 month after ACS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
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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.
Vyacheslav Ryabov, MD,PhD principal investigator
Research Institute for Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with ACS and MRI in people with Acute Coronary Syndrome, run by Russian Academy of Medical Sciences 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 4 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: status not confirmed, as of the sponsor's last update on 14 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vyacheslav Ryabov, MD,PhD (+73822553689, rvvt@cardio-tomsk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue (time frame: 14 days after ACS). The study lists 2 primary outcomes in all. 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 14 Jan 2016.