The Massachusetts General Hospital Optical Coherence Tomography Registry
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| First Received Date ICMJE | April 22, 2010 | ||||
| Last Updated Date | March 4, 2013 | ||||
| Start Date ICMJE | August 2010 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01110538 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Massachusetts General Hospital Optical Coherence Tomography Registry | ||||
| Official Title ICMJE | 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. |
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| 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 ICMJE | Observational | ||||
| Study Design ICMJE | 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. |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3000 | ||||
| Estimated Completion Date | June 2018 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01110538 | ||||
| Other Study ID Numbers ICMJE | 2010-P-000387 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Ik-Kyung Jang, MD, PhD | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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