Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease (MERGING)

November 27, 2018 updated by: Pedro A. Lemos, InCor Heart Institute
This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403000
        • InCor -Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization OR triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
  • Total SYNTAX score > 22
  • LCx and RCA territories estimated to be equivalently revascularized by either PCI or CABG, with at least one major non-LAD vessel to be treated

  • Clinical and anatomic eligibility for both PCI and CABG as agreed to by both interventional and surgical consensus

    • Interventionalist determines PCI appropriateness and eligibility
    • Surgeon determines surgical appropriateness and eligibility

  • Silent ischemia, stable angina, unstable angina or recent MI

    • If recent MI, cardiac biomarkers must have returned to normal prior to randomization
  • Ability to sign informed consent and comply with all study procedures

Exclusion Criteria:

  • Prior PCI or CABG at any time prior to randomization
  • Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
  • Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
  • Patients requiring additional surgery (cardiac or non cardiac) within one year
  • The presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by PCI, but rather should be managed with CABG or medical therapy - reasons will be documented)
  • The presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by CABG, but rather should be managed with PCI. or medical therapy - reasons will be documented)
  • Non cardiac co-morbidities with life expectancy less than 1 year
  • Other investigational drug or device studies that have not reached their primary endpoint.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hybrid Revascularization
The hybrid myocardial revascularization group will be accomplished by a two-step scheme, comprised by off-pump LIMA-to-left anterior descending grafting, followed by percutaneous coronary interventions with Promus Element (everolimus second generation drug eluting stent) for the remaining coronary lesions.
Procedure: Hybrid Revascularization
Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.
Other: Conventional Surgical Coronary Bypass Grafting
Conventional Coronary Artery Bypass Grafts with in pump technique.
Procedure: Conventional Coronary Artery Bypass Surgery
On pump coronary artery by-pass surgery
Other Names:
  • Surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Revascularization Procedure Proposed by the Heart Team
Time Frame: 30 days
The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events
Time Frame: 1 year
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
1 year
Major Adverse Cardiovascular Events
Time Frame: 2 years
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
2 years
Major Adverse Cardiovascular Events
Time Frame: 3 years
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
3 years
Major Adverse Cardiovascular Events
Time Frame: 4 years
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
4 years
Major Adverse Cardiovascular Events
Time Frame: 5 years
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
5 years
Major Adverse Cardiovascular Events
Time Frame: 180 days
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
180 days
Safety
Time Frame: 1 year
Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.
1 year
Recurrence of Angina
Time Frame: 1 year
Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)
1 year
Medication Impact
Time Frame: 1 year
Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.
1 year
Stent Thrombosis
Time Frame: 1 year
Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria
1 year
Bleeding
Time Frame: 1 year
Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria
1 year
Neurological Events
Time Frame: 1 year
Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.
1 year
Graft Patency
Time Frame: 1 year
Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography
1 year
Clinical and Angiographic Scores Correlation with Prognostic
Time Frame: 1 year
Evaluate the clinical correlation between the revascularization strategy and the usefulness of the SYNTAX score, ACEF score, clinical SYNTAX score, logistic EuroSCORE, STS score and InsCor for prognostic evaluation
1 year
Efficacy of the Strategy
Time Frame: 1 year
Evaluate and compare the rate of repeated revascularization (target lesions and target vessels) in each one of both strategies.
1 year
Symptomatic Graft Occlusion
Time Frame: 1 Year
Evaluate patients that presented with recurrent ischaemia symptoms due to graft occlusion. The diagnostic must be done by angiography or angiotomography.
1 Year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life.
Time Frame: 5 years
5 years
Cost
Time Frame: 5 years
Evaluate and compare the final cost of the procedure and follow up period of the patients enrolled in each one of the strategies.
5 years
Hospital Stay
Time Frame: 1 year
Evaluate and compare the period of hospital stay of the patients enrolled in each one of the strategies.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InCor Heart Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MERGING

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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