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

NCT02315924 | Unknown DMC

• 1 other identifier: COCCAICOCA
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Stenosis; Cerebral Stenosis

Outcome Measures

Primary Outcomes (2)

• stroke

  1 year

• acute myocardial infarction

  1 year

Secondary Outcomes (4)

• extracranial arterial stenosis

  2 years

• intracranial arterial stenosis

  2 years

• coronary stenosis severity

  2 years

• coronary stenosis extent

  2 years

Other Outcomes (1)

• inflammation marker

  2 years

Study Arms (2)

coronary and cerebral stenosis

EXPERIMENTAL

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

coronary or cerebral stenosis

ACTIVE COMPARATOR

Other: staged coronary and cerebral intervention

Interventions

simultaneous coronary and cerebral intervention OTHER

Simultaneous strategy is considered that coronary and cerebral intervention will be performed via the same access and within the same day.

coronary and cerebral stenosis

staged coronary and cerebral intervention OTHER

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

coronary and cerebral stenosis; coronary or cerebral stenosis

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-80 years old;
• Patients with clinical indication for coronary angiography;
• Patients with suspected cerebrovascular atherosclerosis;
• Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100050, China

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Buxing Chen, MD, Ph.D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Fu, MD, Ph.D

CONTACT

861067096562; fuqiang66882000@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of cardiology

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 12, 2014
• Study Start: March 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

CN (1)