The Massachusetts General Hospital Optical Coherence Tomography Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01110538 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 26, 2010
Last Update Posted
: November 25, 2016
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Sponsor:
Ik-Kyung Jang, MD, PhD
Collaborators:
Medtronic
Boston Scientific Corporation
Massachusetts General Hospital
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Tracking Information | ||||
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First Submitted Date | April 22, 2010 | |||
First Posted Date | April 26, 2010 | |||
Last Update Posted Date | November 25, 2016 | |||
Study Start Date | August 2010 | |||
Estimated Primary Completion Date | May 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Major adverse cardiac events (MACE) [ Time Frame: 1 year ] | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT01110538 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | The Massachusetts General Hospital Optical Coherence Tomography Registry | |||
Official Title | The Massachusetts General Hospital Optical Coherence Tomography Registry | |||
Brief Summary | Information will be collected prospectively in about 3,000 patients having Optical Coherence Tomography during cardiac catheterization. Subjects will be initially enrolled at sites outside of the United States, where Optical Coherence Tomography is approved by regulatory agencies. Subjects will be followed for up to 5 years. | |||
Detailed Description | This project will create a prospective registry of 3,000 patients with follow-ups of up to 5 years. The aims of the project will be:
Because detailed clinical, angiographic and intravascular imaging data will be gathered from a large number of patients with clinical follow-ups, we anticipate that the registry will be a tremendous resource for additional research questions going forward. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Subjects who have intracoronary OCT imaging performed during cardiac catheterization are eligible for this registry. Subjects may be identified prior to or after cardiac catheterization and OCT imaging. | |||
Condition | Coronary Artery Disease | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Actual Enrollment |
2714 | |||
Original Estimated Enrollment |
3000 | |||
Estimated Study Completion Date | May 2019 | |||
Estimated Primary Completion Date | May 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01110538 | |||
Other Study ID Numbers | 2010-P-000387 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital | |||
Study Sponsor | Ik-Kyung Jang, MD, PhD | |||
Collaborators |
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Investigators |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | November 2016 |