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

Coronary Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02315924
• Other study ID #: COCCAICOCA
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2014
• Last updated: July 19, 2016
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Capital Medical University
• Contact: Qiang Fu, MD, Ph.D
• Phone: 861067096562
• Email: fuqiang66882000[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Stenosis
• Constriction, Pathologic
• Coronary Stenosis

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	inflammation marker	myeloperoxidase, lipoprotein-associated phospholipase A2, oxidized low density lipoprotein, C-reaction protein, F2-isoprostane, leptin, adiponectin.	2 years	No
Primary	stroke		1 year	Yes
Primary	acute myocardial infarction		1 year	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No