Coronary Artery DiseaseNCT00722748
Genomic Investigation of Cardiovascular Diseases
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
This proposal puts forward a research plan to initiate a genetic databank, henceforth referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic research at Scripps as we strive to stay at the forefront of cardiovascular research in the new century. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, Atrial Fibrillation
- How many people
- 15,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from Scripps Health general diagnostic population, cardiology population, and outside referrals. Upon meeting the inclusion/exclusion criteria, each eligible patient will be given a consent form and the study will be discussed with them in a face-to-face discussion with the principal investigator, one of the co-investigators or one of the research coordinators. The patient (or legal representative) must sign the informed consent form prior to any study related procedures being performed.
Who may be able to join
- Candidates for this study must meet ALL of the following criteria:
- Age 18 years or older
- Be reliable, cooperative and willing to comply with all protocol-specified procedures and sub-study if consented.
- Able to understand and grant informed consent
- Have at least one of the following (a-g):
- Coronary Artery Disease (defined as):
Show all 30Show fewer
- Coronary artery bypass surgery or
- Lesion >70% on cardiac or CT angiogram or
- Percutaneous Coronary Intervention
- Myocardial infarction (defined as):
- Diagnosed by elevated troponin level or
- Diagnosed by ST segment elevations on EKG or
- Diagnosed by pathologic Q waves on EKG or
- Documented in the medical record or by self report
- Atrial Fibrillation (defined as):
- Lone Atrial fibrillation (paroxysmal, persistent or permanent); OR
- Lone Atrial Flutter (paroxysmal, persistent or permanent)
- Automatic Internal Cardiac Defibrillator
- Aortic Stenosis (defined by):
- Calculated Aortic Valve Area ≤ 1.0 cm² or
- Mean Pressure Gradient ≥ 40 mmHg or
- Peak Pressure Gradient ≥ 64 mmHg or
- Dimensionless Index < .25 or
- Prior or planned Aortic Valve Replacement for Aortic Stenosis
- Mitral Regurgitation (insufficiency) (defined as)
- Moderate to Severe (equivalent to +3 to +4) mitral regurgitation (insufficiency) on transthoracic echocardiogram as determined by the reading physician and structurally abnormal valve (i.e. myxomatous) and/or thickened or redundant leaflets; OR
- Prior or planned Mitral Valve repair or replacement for mitral regurgitation
- Idiopathic (non-ischemic) Cardiomyopathy (defined as):
- Diagnosed < age 40; OR
- Non-ischemic etiology confirmed by cardiac angiography or CT angiography (may have non-obstructive or stable coronary artery disease if diagnosis of non-ischemic etiology of CM is established by cardiologist).
Who cannot join
- Patients will be excluded if ANY of the following conditions apply:
- Previously enrolled in The Genebank at Scripps Clinic Registry
- Any active bleeding (i.e. GI bleed).
- Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study
- Treatment with any investigational agents or devices within 30 days preceding enrollment in the study.
- Been administered or taken any CNS sedatives or depressants in the past 12 hours.
Show all 36Show fewer
- Been administered or taken any CNS sedatives or depressants in the past 12 hours.
- Subject's qualifying diagnosis is Atrial fibrillation and they are known to have any one of the following:
- Prior myocardial infarction, coronary artery bypass surgery, or percutaneous coronary intervention
- EF < 45% at time of diagnosis (excluding tachycardia induced cardiomyopathy diagnosed by a cardiologist)
- Elevated left atrial pressures (> 20 mmHg)
- Dilated left atrium (> 4.0 cm or >2.0 cm/m2 body surface)
- Mitral valve disease with significant valve pathology
- Mitral regurgitation/insufficiency greater than trace to mild on echo as determined by reading physician
- Rheumatic mitral valve disease
- Congestive heart failure prior to diagnosis
- Hypertrophic cardiomyopathy
- Diagnosis following coronary artery bypass or valve replacement surgery
- Post heart transplant
- Congenital heart disease
- Diagnosed in setting of hyperthyroid
- COPD
- Obstructive sleep apnea
- Subject's qualifying diagnosis is Aortic Stenosis and they are known to have any one of the following:
- Bicuspid valve or other congenital abnormality of the aorta or aortic valve
- Evidence of Rheumatic involvement of the Aortic Valve
- Subject's qualifying diagnosis is Mitral regurgitation (insufficiency) and they are known to have any one of the following:
- Ejection fraction <50%
- Evidence of significant ischemic disease with regions of akinetic myocardium
- Rheumatic changes on echocardiogram (as determined by the reading physi4ian)
- 5. Significant Mitral stenosis (greater than "mild" on echocardiogram as determined by the reading physician) 6. Evidence of valve perforation 7. Evidence of congenital abnormality (i.e. cleft valve)
- Subject's qualifying diagnosis is Idiopathic (non-ischemic) cardiomyopathy and they are known to have any one of the following:
- Ischemic cardiomyopathy
- Hypertrophic cardiomyopathy
- Viral cardiomyopathy
- Alcohol/drug induced cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Genebank at Scripps Clinic Registry
This proposal puts forward a research plan to initiate a genetic databank, henceforth referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic research at Scripps as we strive to stay at the forefront of cardiovascular research in the new century. Human subject donation allows for the creation of the proposed genebank.
Read the detailed description
The completion of the human genome project within the final months of the previous millennium, is a landmark of scientific accomplishment. This achievement heralds the importance human and molecular genetics will play in the coming century in medicine. In short, one expects that dissecting the phenotypic aspects of disease to a culprit mutation/variation of a gene or collection of genes, will modify and or augment our present diagnostic ability leading on to new therapeutic interventions that are targeted based on these discoveries.
The broad application of human genetics will progress from the study of rare mendelian traits with complete penetrance compiled over the last 3-4 decades to a large number of "common" diseases that have multi-gene etiology with variable penetrance such as non-insulin dependent diabetes mellitus and hypertension. Cardiology will probably stay at a forefront of this transformation, as cardiovascular diseases (CVD) remain the major source of morbidity and mortality in developing countries, and is fast reaching the same status in the underdeveloped countries. Furthermore, the track record of rapid adaptation of new technology and research in the field of cardiology, would give further impetus to this transition. In the midst of these dynamic currents, this proposal puts forward a research plan to initiate a genetic databank, henceforth referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic research at Scripps as we strive to stay at the forefront of cardiovascular research in the new century.
The objective of this study is, to obtain blood samples in order to define genes for various cardiovascular conditions. The blood samples will go through DNA analysis and noted for 1 million SNP's per individual.
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Atrial Fibrillation, Aortic Stenosis, Mitral Regurgitation, Idiopathic Cardiomyopathy
- Keywords
- Genebank, Gene registry, Cardiac Arrythmia Disease
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Atrial Fibrillation, Aortic Valve Stenosis, Mitral Valve Insufficiency, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Genebank | By creating a genebank from patient's blood donations we will ultimately be able to define genes for various cardiovascular conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
38 cc of blood obtained for DNA analysis. Medical information -diagnosis, disease history, medical treatments, response to treatments, laboratory tests, subject's age, ethnic background, and if available, related family history.
Measured: At the time of informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionSep 2025 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
- Investigators
- Eric J Topol, MD, Principal investigator, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722748
- Sponsor's protocol ID
- HSC004714
- Status last verified
- Jan 2025
- First submitted
- 24 Jul 2008
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genebank at Scripps Clinic Registry
- ClinicalTrials.gov ID
- NCT00722748
- Acronym / sponsor ID
- HSC004714
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Atrial Fibrillation, Aortic Stenosis, Mitral Regurgitation, Idiopathic Cardiomyopathy
- Keywords
- Genebank, Gene registry, Cardiac Arrythmia Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal puts forward a research plan to initiate a genetic databank, henceforth referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic research at Scripps as we strive to stay at the forefront of cardiovascular research in the new century. Human subject donation allows for the creation of the proposed genebank.
Detailed description
The completion of the human genome project within the final months of the previous millennium, is a landmark of scientific accomplishment. This achievement heralds the importance human and molecular genetics will play in the coming century in medicine. In short, one expects that dissecting the phenotypic aspects of disease to a culprit mutation/variation of a gene or collection of genes, will modify and or augment our present diagnostic ability leading on to new therapeutic interventions that are targeted based on these discoveries.
The broad application of human genetics will progress from the study of rare mendelian traits with complete penetrance compiled over the last 3-4 decades to a large number of "common" diseases that have multi-gene etiology with variable penetrance such as non-insulin dependent diabetes mellitus and hypertension. Cardiology will probably stay at a forefront of this transformation, as cardiovascular diseases (CVD) remain the major source of morbidity and mortality in developing countries, and is fast reaching the same status in the underdeveloped countries. Furthermore, the track record of rapid adaptation of new technology and research in the field of cardiology, would give further impetus to this transition. In the midst of these dynamic currents, this proposal puts forward a research plan to initiate a genetic databank, henceforth referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic research at Scripps as we strive to stay at the forefront of cardiovascular research in the new century.
The objective of this study is, to obtain blood samples in order to define genes for various cardiovascular conditions. The blood samples will go through DNA analysis and noted for 1 million SNP's per individual.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genebank | – | –By creating a genebank from patient's blood donations we will ultimately be able to define genes for various cardiovascular conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from Scripps Health general diagnostic population, cardiology population, and outside referrals. Upon meeting the inclusion/exclusion criteria, each eligible patient will be given a consent form and the study will be discussed with them in a face-to-face discussion with the principal investigator, one of the co-investigators or one of the research coordinators. The patient (or legal representative) must sign the informed consent form prior to any study related procedures being performed.
Key inclusion criteria (30 listed)
- Age 18 years or older
- Be reliable, cooperative and willing to comply with all protocol-specified procedures and sub-study if consented.
- Able to understand and grant informed consent
- Have at least one of the following (a-g):
Key exclusion criteria (36 listed)
- Previously enrolled in The Genebank at Scripps Clinic Registry
- Any active bleeding (i.e. GI bleed).
- Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study
- Treatment with any investigational agents or devices within 30 days preceding enrollment in the study.
- Been administered or taken any CNS sedatives or depressants in the past 12 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
38 cc of blood obtained for DNA analysis. Medical information -diagnosis, disease history, medical treatments, response to treatments, laboratory tests, subject's age, ethnic background, and if available, related family history.
Time frame: At the time of informed consent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- The webpage for Scripps Translational Science InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Topol, MD principal investigator
Scripps Translational Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
38 cc of blood obtained for DNA analysis. Medical information -diagnosis, disease history, medical treatments, response to treatments, laboratory tests, subject's age, ethnic background, and if available, related family history. (time frame: At the time of informed consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.