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Combined Coronary and Cerebral Angiography and Intervention for Coronary and Cerebrovascular Atherosclerosis

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ClinicalTrials.gov Identifier: NCT02315924
Recruitment Status : Unknown
Verified July 2016 by Buxing Chen, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : December 12, 2014
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Buxing Chen, Capital Medical University

Brief 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 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.


Condition or disease Intervention/treatment Phase
Coronary Stenosis Cerebral Stenosis Other: simultaneous coronary and cerebral intervention Other: staged coronary and cerebral intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: coronary and cerebral stenosis Other: simultaneous coronary and cerebral intervention
Simultaneous strategy is considered that coronary and cerebral intervention will be performed via the same access and within the same day.

Other: staged coronary and cerebral intervention
Staged strategy was intended that coronary or cerebral intervention will be performed within 7 days from the first procedure.

Active Comparator: coronary or cerebral stenosis Other: staged coronary and cerebral intervention
Staged strategy was intended that coronary or cerebral intervention will be performed within 7 days from the first procedure.




Primary Outcome Measures :
  1. stroke [ Time Frame: 1 year ]
  2. acute myocardial infarction [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. extracranial arterial stenosis [ Time Frame: 2 years ]
    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.

  2. intracranial arterial stenosis [ Time Frame: 2 years ]
    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%).

  3. coronary stenosis severity [ Time Frame: 2 years ]
    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%.

  4. coronary stenosis extent [ Time Frame: 2 years ]
    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.


Other Outcome Measures:
  1. inflammation marker [ Time Frame: 2 years ]
    myeloperoxidase, lipoprotein-associated phospholipase A2, oxidized low density lipoprotein, C-reaction protein, F2-isoprostane, leptin, adiponectin.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 20-80 years old;
  2. Patients with clinical indication for coronary angiography;
  3. Patients with suspected cerebrovascular atherosclerosis;
  4. Written informed consent.

Exclusion Criteria:

  1. Patients who have symptomatic congestive heart failure (New York Heart Association Class III or IV)
  2. Patients who develop acute myocardial infarction
  3. The presence of severe liver disease including chronic active hepatitis, or chronic jaundice with hyperbilirubinemia
  4. Patients with renal dysfunction, or with nephrotic syndrome
  5. Patients with cancer
  6. Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315924


Contacts
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Contact: Qiang Fu, MD, Ph.D 861067096562 fuqiang66882000@hotmail.com

Locations
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China
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, China, 100050
Contact: Qiang Fu, Dr    861067096562    fuqiang66882000@hotmail.com   
Principal Investigator: Buxing Chen, Dr         
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Buxing Chen, MD, Ph.D Beijing Tiantan Hospital

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Responsible Party: Buxing Chen, Director of department of cardiology, Capital Medical University
ClinicalTrials.gov Identifier: NCT02315924     History of Changes
Other Study ID Numbers: COCCAICOCA
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Coronary Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases