Coronary StenosisNCT02315924
Combined Coronary and Cerebral Angiography and Intervention for Coronary and Cerebrovascular Atherosclerosis
A study testing simultaneous coronary and cerebral intervention and staged coronary and cerebral intervention in people with Coronary Stenosis and Cerebral Stenosis, run by Capital Medical University at 1 site in China.
Trial summary
Intracranial atherosclerosis is common vascular lesion in Asian acute stroke patients and intracranial atherosclerosis patients have high rate of coronary artery disease (CAD). Moreover, several studies showed obvious association of CAD and cerebrovascular stenosis, which had been proved to increase the risk of stroke… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Stenosis, Cerebral Stenosis
- What is being tested?
- simultaneous coronary and cerebral intervention and staged coronary and cerebral intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Dec 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-80 years old;
- Patients with clinical indication for coronary angiography;
- Patients with suspected cerebrovascular atherosclerosis;
- Written informed consent.
Who cannot join
- Patients who have symptomatic congestive heart failure (New York Heart Association Class III or IV)
- Patients who develop acute myocardial infarction
- The presence of severe liver disease including chronic active hepatitis, or chronic jaundice with hyperbilirubinemia
- Patients with renal dysfunction, or with nephrotic syndrome
- Patients with cancer
- Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
Qiang Fu, Dr, 861067096562, fuqiang66882000@hotmail.com
Buxing Chen, Dr
About this study
Official title: An Open-label, Single-centre Study Evaluating the Prevalence and Characteristics of Coronary and Cerebrovascular Arteriosclerosis as Measured by Combined Coronary and Cerebral Angiography, and Comparing the Efficacy and Safety of Simultaneous or Staged Coronary and Cerebral Interventional Strategy in Chinese Patients
Intracranial atherosclerosis is common vascular lesion in Asian acute stroke patients and intracranial atherosclerosis patients have high rate of coronary artery disease (CAD). Moreover, several studies showed obvious association of CAD and cerebrovascular stenosis, which had been proved to increase the risk of stroke after coronary revascularization including coronary bypass surgery or percutaneous coronary intervention. In addition, the efficacy and safety of combined coronary and cerebral intervention are not fully investigated. Hence, the aim of this study is to evaluate the prevalence and characteristics of coronary and cerebrovascular arteriosclerosis as measured by combined coronary and cerebral angiography, explore the relationship between inflammation, atherosclerosis-related markers and coronary and cerebral atherosclerosis and compare the efficacy and safety of simultaneous or staged coronary and cerebral interventional strategy in Chinese Patients.
The coronary angiography and cerebrovascular angiography are performed for all participants. The combined strategy for coronary and cerebrovascular angiography is carried out routinely in the investigators institutions. Simultaneous strategy is considered as that performed via the same access and within the same day. Staged strategy is intended as that performed within 7 days from the first procedure. The sequence of angiographies is established on an individual patient basis by the cardiovascular and neurointerventional team according to clinical symptoms of the patients and after coronary or cerebrovascular angiography. After combined coronary and cerebral angiography, simultaneous or staged interventional strategy will be performed in patients with severe coronary and cerebral stenosis. Blood sample is obtained from artery sheath when performing coronary or cerebral angiography. Lipid levels, inflammation and atherosclerosis-related markers will be measured in this study.
- Conditions
- Coronary Stenosis, Cerebral Stenosis
- Being tested
- simultaneous coronary and cerebral intervention, staged coronary and cerebral intervention
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous coronary and cerebral interventionOther
Simultaneous strategy is considered that coronary and cerebral intervention will be performed via the same access and within the same day.
staged coronary and cerebral interventionOther
Staged strategy was intended that coronary or cerebral intervention will be performed within 7 days from the first procedure.
| Study group | Role | What they receive |
|---|---|---|
| coronary and cerebral stenosis | Experimental | Not described Receives: Other: simultaneous coronary and cerebral intervention; Other: staged coronary and cerebral intervention |
| coronary or cerebral stenosis | Active comparator | Not described Receives: Other: staged coronary and cerebral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke
Measured: 1 year
acute myocardial infarction
Measured: 1 year
Secondary outcomes (4)
extracranial arterial stenosis
North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria were used for extracranial carotid stenosis calculations.The degree of extracranial carotid stenosis and stenosis in the extracranial segment of the vertebral artery was classified as normal, <50%, 50-69%, 70-89%, and 90-99% stenosis, or occluded. We defined angiographic extracranial arterial stenosis as a diameter stenosis of >70% on the common carotid artery, the carotid bifurcation, the internal carotid artery, and vertebral artery.
Measured: 2 years
intracranial arterial stenosis
Intracranial stenoses were measured according to the methods described in the Warfarin-Aspirin for Symptomatic Intracranial Disease Study. The degree of stenosis in the intracranial segment of the internal carotid artery, stenosis in the intracranial segment of the vertebral artery, and stenosis in the basilar artery were classified as normal or ≤25%, 25-49%, ≥50% stenosis and occlusion. We defined angiographic intracranial cerebral artery stenosis as a diameter stenosis of >50% on the intracranial segment of the internal carotid artery and the vertebral artery, and the basilar artery. Stenoses were classified as moderate (50-69%) or severe (70-99%).
Measured: 2 years
coronary stenosis severity
The modified Gensini's stenosis scoring system was used to assess the severity of coronary lesions. The Gensini score was calculated by assigning a severity score to each coronary stenosis according to the degree of luminal narrowing and its geographic importance. Severity scores assigned to the specific percentage luminal diameter reduction of the coronary artery segment were 32 for 100%, 16 for 99%, 8 for 75%, 2 for 50%, and 1 for 25%.
Measured: 2 years
coronary stenosis extent
According to the number of diseased vessels, all patients were classified into: no vessel disease (VD); 1-VD; 2-VD; 3-VD; left main trunk disease.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buxing Chen, Capital Medical University
- Investigators
- Buxing Chen, MD, Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315924
- Sponsor's protocol ID
- COCCAICOCA
- Status last verified
- Jul 2016
- First submitted
- 2 Dec 2014
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-centre Study Evaluating the Prevalence and Characteristics of Coronary and Cerebrovascular Arteriosclerosis as Measured by Combined Coronary and Cerebral Angiography, and Comparing the Efficacy and Safety of Simultaneous or Staged Coronary and Cerebral Interventional Strategy in Chinese Patients
- ClinicalTrials.gov ID
- NCT02315924
- Acronym / sponsor ID
- COCCAICOCA
- Conditions
- Coronary Stenosis, Cerebral Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Dec 2014 (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.
Intracranial atherosclerosis is common vascular lesion in Asian acute stroke patients and intracranial atherosclerosis patients have high rate of coronary artery disease (CAD). Moreover, several studies showed obvious association of CAD and cerebrovascular stenosis, which had been proved to increase the risk of stroke after coronary revascularization including coronary bypass surgery or percutaneous coronary intervention. In addition, the efficacy and safety of combined coronary and cerebral intervention are not fully investigated. Hence, the aim of this study is to evaluate the prevalence and characteristics of coronary and cerebrovascular arteriosclerosis as measured by combined coronary and cerebral angiography, explore the relationship between inflammation, atherosclerosis-related markers and coronary and cerebral atherosclerosis and compare the efficacy and safety of simultaneous or staged coronary and cerebral interventional strategy in Chinese Patients.
The coronary angiography and cerebrovascular angiography are performed for all participants. The combined strategy for coronary and cerebrovascular angiography is carried out routinely in the investigators institutions. Simultaneous strategy is considered as that performed via the same access and within the same day. Staged strategy is intended as that performed within 7 days from the first procedure. The sequence of angiographies is established on an individual patient basis by the cardiovascular and neurointerventional team according to clinical symptoms of the patients and after coronary or cerebrovascular angiography. After combined coronary and cerebral angiography, simultaneous or staged interventional strategy will be performed in patients with severe coronary and cerebral stenosis. Blood sample is obtained from artery sheath when performing coronary or cerebral angiography. Lipid levels, inflammation and atherosclerosis-related markers will be measured in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronary and cerebral stenosis | Experimental | Other: simultaneous coronary and cerebral intervention, Other: staged coronary and cerebral intervention |
| coronary or cerebral stenosis | Active comparator | Other: staged coronary and cerebral intervention |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20-80 years old;
- Patients with clinical indication for coronary angiography;
- Patients with suspected cerebrovascular atherosclerosis;
- Written informed consent.
Key exclusion criteria (6 listed)
- Patients who have symptomatic congestive heart failure (New York Heart Association Class III or IV)
- Patients who develop acute myocardial infarction
- The presence of severe liver disease including chronic active hepatitis, or chronic jaundice with hyperbilirubinemia
- Patients with renal dysfunction, or with nephrotic syndrome
- Patients with cancer
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 |
|---|---|---|
| simultaneous coronary and cerebral interventionSimultaneous strategy is considered that coronary and cerebral intervention will be performed via the same access and within the same day. | Other | coronary and cerebral stenosis |
| staged coronary and cerebral interventionStaged strategy was intended that coronary or cerebral intervention will be performed within 7 days from the first procedure. | Other | coronary and cerebral stenosis, coronary or cerebral stenosis |
Primary outcome
stroke
Time frame: 1 year
acute myocardial infarction
Time frame: 1 year
4 secondary outcomes
extracranial arterial stenosis
Time frame: 2 years
intracranial arterial stenosis
Time frame: 2 years
coronary stenosis severity
Time frame: 2 years
coronary stenosis extent
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Buxing Chen, MD, Ph.D principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simultaneous coronary and cerebral intervention and staged coronary and cerebral intervention in people with Coronary Stenosis and Cerebral Stenosis, run by Capital Medical University at 1 site in China.
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 6 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 21 Jul 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 China. 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 Qiang Fu, MD, Ph.D (861067096562, fuqiang66882000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke (time frame: 1 year). 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 21 Jul 2016.