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NCT03447938 · ClinicalTrials.gov registry record · NA
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
A NA study of Coronary Artery Disease, sponsored by Ottawa Heart Institute Research Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 176
- Enrollment target
- 13
- Study locations
NCT03447938: Recruiting NA study of Coronary Artery Disease, sponsored by Ottawa Heart Institute Research Corporation.
NCT03447938 is a NA study of Coronary Artery Disease that is actively recruiting participants, run by Ottawa Heart Institute Research Corporation. The registered enrollment target is 176 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (86% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03447938, a NA study of Coronary Artery Disease, is actively recruiting participants, sponsored by Ottawa Heart Institute Research Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 176 participants
- Enrollment target
- 13
- Study locations
Study Summary
MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG) is completed through a small incision over the left chest, has evolved to become a safe and less invasive alternative to conventional sternotomy CABG. Several observational studies have suggested significantly shorter time to return to physical activity for MICS CABG patients compared to sternotomy CABG patients. A randomized study is warranted to validate these findings, provide higher level of evidence, and potentially lead to changes in practice. The MIST Trial is a multi-centre, prospective, open label, randomized control trial comparing quality of life and recovery in the early post-operative period, between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients referred for isolated CABG for multi-vessel coronary artery disease and deemed technically suitable for sternotomy CABG as well as for MICS CABG are considered for enrollment into the trial. Quality of life questionnaires (The SF-36, Seattle Angina Questionnaire and EQ-5D-5L) will be used to assess the quality of life and recovery in patients undergoing sternotomy CABG or MICS CABG at 1 month, 3 months, 6 months and 12 months follow up.
Primary Outcome
Comparison of the physical quality of life between the two groups four weeks after surgery using the physical function score of the 36-Item Short Form Health Survey (SF-36). The physical function score is a scale from 0 (poor physical function) to 100 (excellent physical function, with an average score of 50. It includes items that assess physical functioning, bodily pain, physical role functioning, vitality, and generally health perceptions. Analysis restricted to high-volume recruiting center
Conditions Studied
Interventions
- PROCEDURE MICS CABG
- PROCEDURE Conventional CABG
Study Locations (13)
Other
- Universitaire Ziekenhuizen Leuven - Leuven
- Robert-Bosch-Hospital - Stuttgart
- National University Hospital (NUH) - Singapore - Singapore
- Far-Eastern Memorial Hospital - Taipei
Ontario
- Division of Cardiac Surgery, University of Ottawa Heart Institute - Ottawa
- University Health Network - Toronto
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Wisconsin
- Gundersen Lutheran Medical Center - La Crosse
Jilin
- Jilin Heart Hospital - Jilin
Saxony
- Leipzig Heart Institute GmbH - Leipzig
Karnataka
- Apollo Hospital, Bangalore - Bangalore
National Capital Territory of Delhi
- Manipal Hospitals - New Delhi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2028-03-01 |
| Phase | NA |
What NCT03447938 shows while recruiting
NCT03447938 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which MICS CABG is the first listed.
NCT03447938 lists 13 locations in 9 states (Other, Ontario, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT03447938 about?
NCT03447938 is a clinical study titled "The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial". MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG) is completed through a small incision over the left chest, has evolved to become a safe and less invasive alternative to conventional sternotomy CABG. Several observational studies have suggested significan...
What is the current status of trial NCT03447938?
This trial is currently recruiting. It is a NA study. The enrollment target is 176 participants. The study started on 2018-09-01. Estimated completion is 2028-03-01.
What conditions does trial NCT03447938 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT03447938?
The interventions under investigation include: MICS CABG (PROCEDURE), Conventional CABG (PROCEDURE).
Who is sponsoring clinical trial NCT03447938?
This trial is sponsored by Ottawa Heart Institute Research Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03447938 being conducted?
This trial has 13 study locations across Pennsylvania, Wisconsin, Ontario, Jilin, Saxony. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03447938's enrollment target sits among peer trials
176 127th of 219 higher than 93 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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