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Cardiovascular DiseasesGATCNCT00590200

GeneBank at the Cleveland Clinic: Molecular Determinants of Coronary Artery Disease

An observational study of Cardiovascular Diseases, run by The Cleveland Clinic.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This proposal delineates a research plan to collect blood from patients undergoing heart catheterization or who have had a heart catheterization within one year and are coming in for outpatient appointments, or who have scheduled cardiac CT scans at the Cleveland Clinic over a five-year period for the purpose of… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
How many people
9,880 participants
Where
No sites listed yet
Study dates
Jan 2001to Dec 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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All Cleveland Clinic patients undergoing cardiac catheterization or have had a heart catheterization within one year, coming in for outpatient appointments, or have scheduled cardiac CT scans or CT scans performed within one year of scheduled blood draw, will be eligible to be enrolled.

Who may be able to join

  • Males or females at least 18 years old.
  • Patient has not been previously enrolled in the genebank registry.
  • Patient able to give informed consent.
  • Patient to undergo cardiac catheterization or had a left heart cath at The Cleveland Clinic or at The University of North Carolina at Chapel Hill, or at MetroHealth Medical Center within 1 year.
  • Patients > or = to 50 y/o with normal cardiac catheterizations (< 30% in all coronary vessels per angio). (If subjects enrolled as normal controls are later deemed to have significant CAD, the subject's blood and data will still be useful in the Genebank under the broader scope of the study).
  • Any patient with history of myocardial infarction. (If a subject reports history of MI at another facility, outside records will be obtained to confirm the diagnosis. If MI cannot be confirmed by data in the record, the subject's blood and data will still be useful in the Genebank under the broader scope of the study).
Show all 11Show fewer
  • Non-caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical; Center only).
  • All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only). (Cleveland Clinic will follow inclusion criteria 1-7, 9, UNC and MetroHealth Medical Center will follow criteria1-8).
  • Any patients coming to the Heart and Vascular Institute for outpatient scheduled appointments.
  • Any patients that have had or are going to have an implanted cardioverter defibrillator (ICD) or Cardiac Resynchronization Defibrillator (CRT-D).
  • Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias.

Who cannot join

  • None except as noted in the inclusion criteria

About this study

Official title: Molecular Determinants of Coronary Artery Disease

This proposal delineates a research plan to collect blood from patients undergoing heart catheterization or who have had a heart catheterization within one year and are coming in for outpatient appointments, or who have scheduled cardiac CT scans at the Cleveland Clinic over a five-year period for the purpose of establishing a gene bank registry. In addition, the University of North Carolina at Chapel Hill will enroll 1,000 non-Caucasian patients and MetroHealth Medical center in Cleveland will enroll 1,000 non-Caucasian patients. The blood collected will be processed to create a repository of DNA, lymphoblastoid cell line immortalization on selected patient populations, plasma and serum. The DNA will be amplified in certain patient populations to preserve the quantity. Along with a sample of blood collected from individual patients, a concise general medical history, demographic data, electrocardiographic data, echocardiographic data (available for about 55% of patients at the present time), and laboratory data will be collected. A short interview will take place after enrollment during the outpatient visit or hospital stay, or may be conducted via phone call after enrollment. All the clinical data gathered will be compiled in GATC heart center database, and would be stored in a format where a culmination of clinical findings, i.e. representing a disease of interest, can be used to search the database to identify the blood samples of all patients with such characteristics for further study.

Read the detailed description

The study is to commence on March 1st 2001 and is to be completed within 2-5 years. The targeted number of patients to be enrolled is 15,000. All patients undergoing cardiac catheterization or have had a heart catheterization within one year, coming in for outpatient appointments, or have scheduled cardiac CT scans or CT scans performed within one year of scheduled blood draw, will be eligible to be enrolled. Patients inclusion criteria are as follows, once informed consent is obtained:

  1. Males or females at least 18 years old.
  2. Patient has not been previously enrolled in the genebank registry.
  3. Patient able to give informed consent.
  4. Patient to undergo cardiac catheterization or had a left heart cath at The Cleveland Clinic or at The University of North Carolina at Chapel Hill, or at MetroHealth Medical Center within 1 year.
  5. Patients > or = to 50 y/o with normal cardiac catheterizations (< 30% in all coronary vessels per angio). (If subjects enrolled as normal controls are later deemed to have significant Coronary Artery Disease (CAD), the subject's blood and data will still be useful in the GeneBank under the broader scope of the study)
  6. Any patient with history of myocardial infarction (MI). (If a subject reports history of MI at another facility, outside records will be obtained to confirm the diagnosis. If MI cannot be confirmed by data in the record, the subject's blood and data will still be useful in the Genebank under the broader scope of the study.)
  7. Non-Caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical Center only)
  8. All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only)
  9. Any patient coming to the Heart and Vascular Institute for outpatient scheduled appointments.
  10. Any patients that have had or are going to have an implanted cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D).
  11. Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias. (Cleveland Clinic will follow inclusion criteria 1-6 and 8-11, UNC and MetroHealth Medical Center will follow criteria 1-11).

Exclusion criteria:

None except as in Inclusion criteria.

Keywords
CAD, Cardiovascular Disease, CVD, MI, Myocardial Infarction, Heart Attack, CABG, Revascularization, genetic
Medical subject headings
Cardiovascular Diseases, Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary Artery Disease

    Development of Coronary Artery Disease

    Measured: 3 years

Secondary outcomes (4)

  1. Death

    All cause mortality

    Measured: 5 years

  2. Revascularization

    Need for revascularization

    Measured: 3 years

  3. Percutaneous Coronary Intervention/Stent

    Need for percutaneous coronary intervention and/or stent

    Measured: 3 years

  4. Myocardial Infarction

    New myocardial infarction

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2008 (estimated)
  2. Study startJan 2001
  3. Primary completionJul 2007
  4. Study completionDec 2030 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
9,880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00590200
Sponsor's protocol ID
IRB 4265
Other IDs
5P50HL077107-02, IRB 4265, GeneBank
Acronym
GATC
Status last verified
Jan 2026
First submitted
26 Dec 2007
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Tang WHW, Nemet I, Li XS, Wu Y, Haghikia A, Witkowski M, Koeth RA, Demuth I, Konig M, Steinhagen-Thiessen E, Backhed F, Fischbach MA, Deb A, Landmesser U, Hazen SL. Prognostic value of gut microbe-generated metabolite phenylacetylglutamine in patients with heart failure. Eur J Heart Fail. 2024 Feb;26(2):233-241. doi: 10.1002/ejhf.3111. Epub 2024 Jan 25.

    PubMed 38124458

  • Witkowski M, Wu Y, Hazen SL, Tang WHW. Prognostic value of subclinical myocardial necrosis using high-sensitivity cardiac troponin T in patients with prediabetes. Cardiovasc Diabetol. 2021 Aug 21;20(1):171. doi: 10.1186/s12933-021-01365-9.

    PubMed 34419046

  • Dupont M, Wu Y, Hazen SL, Tang WH. Cystatin C identifies patients with stable chronic heart failure at increased risk for adverse cardiovascular events. Circ Heart Fail. 2012 Sep 1;5(5):602-9. doi: 10.1161/CIRCHEARTFAILURE.112.966960. Epub 2012 Aug 16.

    PubMed 22899766

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by The Cleveland Clinic.

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 11 inclusion and 1 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Coronary Artery Disease (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00590200, which also lists 3 linked publications.

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 25 Jun 2026.

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