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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Stenosis; Cerebral Stenosis
• Intervention / Treatment: Other: simultaneous coronary and cerebral intervention; Other: staged coronary and cerebral intervention

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
    • Contact: Qiang Fu, Dr; Phone Number: 861067096562; Email: fuqiang66882000@hotmail.com
    • Principal Investigator: Buxing Chen, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
stroke	1 year
acute myocardial infarction	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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%).	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%.	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.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammation marker	myeloperoxidase, lipoprotein-associated phospholipase A2, oxidized low density lipoprotein, C-reaction protein, F2-isoprostane, leptin, adiponectin.	2 years

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Buxing Chen, MD, Ph.D, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 12, 2014

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: COCCAICOCA