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

NCT ID: NCT02315924

Last Updated: 2016-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Stenosis Cerebral Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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coronary and cerebral stenosis

Group Type EXPERIMENTAL

simultaneous coronary and cerebral intervention

Intervention Type OTHER

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 intervention

Intervention Type OTHER

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

coronary or cerebral stenosis

Group Type ACTIVE_COMPARATOR

staged coronary and cerebral intervention

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Buxing Chen

Director of department of cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Buxing Chen, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiang Fu, MD, Ph.D

Role: CONTACT

861067096562

Facility Contacts

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Qiang Fu, Dr

Role: primary

861067096562

Other Identifiers

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COCCAICOCA

Identifier Type: -

Identifier Source: org_study_id

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