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

Capital Medical University

Status: Unknown

Conditions: Cerebral Stenosis; Coronary Stenosis

Treatments: Other: simultaneous coronary and cerebral intervention; Other: staged coronary and cerebral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02315924

COCCAICOCA

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

coronary and cerebral stenosis

Experimental group

Treatment:

Other: simultaneous coronary and cerebral intervention

Other: staged coronary and cerebral intervention

coronary or cerebral stenosis

Active Comparator group

Treatment:

Other: staged coronary and cerebral intervention