Molecular Determinants of Coronaruy Artery Disease | NCT00590291

Studies
Molecular Determinants of Coronaruy Artery Disease

NCT00590291

Sponsor

John Barnard

Status

Terminated

Last Update Posted

May 17, 2021Actual

Enrollment

1,461Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Arteriovenous Malformations
Myocardial Infarction

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB4333	Other Identifier	Cleveland Clinic IRB
1R01HL121358	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sequencing completed early

Expanded Access Info

Start Date

Jan 1995Actual

Primary Completion Date

Apr 1, 2021Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

Dec 27, 2007

First Submission Date that Met QC Criteria

Dec 27, 2007

First Posted Date

Jan 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2021

Last Update Posted Date

May 17, 2021Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to discover genes that may cause Coronary Artery Disease (CAD) or Arteriovenous Malformation (AVM).

Detailed Description

The purpose of this study is to discover genes that may cause Coronary Artery Disease (CAD) or Arteriovenous Malformation (AVM). Many human diseases are inherited or passed from parent to child in families. These diseases occur because of damage to a gene(s), the genetic material that is also called DNA. Scientists can now use modern molecular techniques to locate and to find certain genes within the DNA (genetic material) of a person, and to follow their inheritance in a family. To find these disease-causing genes requires studies of many affected with the disease and their family members. The purpose of this study is to locate and to find the genes for coronary artery disease (CAD) which occurs when one or more of the arteries that carry oxygen-rich blood from your heart to the rest of your body develop blockages; or, arteriovenous malformation (AVM) which causes abnormal vascular connections between arteries and veins, particularly near the heart. Findings of the genes causing CAD and AVM will have far-reaching effect on the diagnosis, treatment, and prevention of coronary artery disease and arteriovenous malformation. These studies will lead to possible genetic diagnosis, early detection of persons at risk for developing CAD or AVM (even in the absence of symptoms), development of effective drugs, more rational and specific therapeutic interventions, treatments and ultimately, prevention of coronary heart disease. Approximately 3-5 years are required to find one human disease gene.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,461Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		premature CAD and MI, AVM
Controls		No CAD, MI, AVM

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary Artery Disease		2009
Arteriovenous Malformation		2009

Secondary Outcomes

Measure	Description	Time Frame
Myocardial Infarction		2009

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males at least 45 years old and premenopausal females at least 50 years old at the time of onset of any of the following:
PTCA
MI
CABG
Must have a living sibling meeting the same criteria.

Exclusion Criteria:

Substance Abuse in the absence of angiographic coronary stenosis
Congenital Heart Disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with CAD or AVM and their family members and 500 normal control individuals The total number enrolled is 2,980, and approximately 2,000 recruited at the Cleveland Clinic.

We will comply with the NIH guidelines by including women and members of minority groups and their subpopulations in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Barnard, PhD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D001165	Arteriovenous Malformations
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

For each participant, 10 ml of blood for lymphoblastoid cell line immortalization, 10-20 ml blood for DNA extraction, or two buccal swabs. If gene identified, blood samples from children to identify the children affected with this gene will be obtained. When available, biopsy tissues for extracting DNA, RNA, protein, or for cell biological studies will be obtained. Human genomic DNA will be prepared from peripheral blood lymphocytes, biopsy tissue, or cell lines derived from Epstein Barr virus transformed lymphocytes 15. DNA will be used for a variety of purposes including linkage analysis and mutational screening.