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

Primary Purpose

Coronary Stenosis, Cerebral Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
simultaneous coronary and cerebral intervention
staged coronary and cerebral intervention
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Stenosis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

coronary and cerebral stenosis

coronary or cerebral stenosis

Arm Description

Outcomes

Primary Outcome Measures

stroke
acute myocardial infarction

Secondary Outcome Measures

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.
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%).
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%.
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.

Full Information

First Posted
December 2, 2014
Last Updated
July 19, 2016
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02315924
Brief Title
Combined Coronary and Cerebral Angiography and Intervention for Coronary and Cerebrovascular Atherosclerosis
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis, Cerebral Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
coronary and cerebral stenosis
Arm Type
Experimental
Arm Title
coronary or cerebral stenosis
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
simultaneous coronary and cerebral intervention
Intervention Description
Simultaneous strategy is considered that coronary and cerebral intervention will be performed via the same access and within the same day.
Intervention Type
Other
Intervention Name(s)
staged coronary and cerebral intervention
Intervention Description
Staged strategy was intended that coronary or cerebral intervention will be performed within 7 days from the first procedure.
Primary Outcome Measure Information:
Title
stroke
Time Frame
1 year
Title
acute myocardial infarction
Time Frame
1 year
Secondary Outcome Measure Information:
Title
extracranial arterial stenosis
Description
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.
Time Frame
2 years
Title
intracranial arterial stenosis
Description
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%).
Time Frame
2 years
Title
coronary stenosis severity
Description
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%.
Time Frame
2 years
Title
coronary stenosis extent
Description
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
inflammation marker
Description
myeloperoxidase, lipoprotein-associated phospholipase A2, oxidized low density lipoprotein, C-reaction protein, F2-isoprostane, leptin, adiponectin.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-80 years old; Patients with clinical indication for coronary angiography; Patients with suspected cerebrovascular atherosclerosis; Written informed consent. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Fu, MD, Ph.D
Phone
861067096562
Email
fuqiang66882000@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buxing Chen, MD, Ph.D
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Fu, Dr
Phone
861067096562
Email
fuqiang66882000@hotmail.com
First Name & Middle Initial & Last Name & Degree
Buxing Chen, Dr

12. IPD Sharing Statement

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

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