The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)

The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on myocardial viability in coronary artery disease patients with single coronary total occlusion (CTO) lesions.

Study Overview

Detailed Description

Patients with coronary artery disease might benefit from successful percutaneous coronary intervention (PCI). However, there is currently no consensus on an optimal treatment modality for single lesions resulting in coronary total occlusion (CTO). Since the other coronary arteries are often lesion-free, or with stenosis of less than 50%, patients often present with no symptoms. Although the expert consensus on CTO lesion suggests reducing the incidence of long-term adverse events via successful revascularization, there are few retrospective studies on single CTO lesions. To date, it is unclear whether successful PCI based on optimal medication treatment (OMT) can increase myocardial viability and the extent of myocardial viability related to prognosis of those CTO patients. Therefore, the aim of this multi-center, prospective, open labeled, non-randomized controlled study was to determine if the improvement to myocardial viability in single CTO patients with successful PCI plus OMT was superior to that of patients with only OMT.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

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

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of stable or unstable angina
  • LVEF > 35% on transthoracic echocardiography measurement
  • Single lesion occluding the coronary artery detected by angiography or MSCTA, with or without stenosis of other coronary arteries (≤ 50% stenotic lesion)
  • Availability for follow-up for up to 12 months
  • No major barriers to provide written consent

Exclusion Criteria:

  • Acute Q-wave myocardial infarction during the latest 3 months
  • Revascularization in the non-culprit artery during the latest one month
  • Unsuitable for PCI
  • Unable to tolerate dual antiplatelet treatment (DAPT)
  • Severe abnormal hematopoietic system, such as platelet count of < 100×109/L or > 700×109/L and white blood cell count of < 3×109/L
  • Active bleeding or bleeding tendency
  • Severe coexisting conditions, such as severe renal insufficiency (GFR < 60 ml/min•1.73m2), severe hepatic dysfunction [elevated ALT (glutamic-pyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
  • Life expectancy < 12 months
  • Pregnancy or planning pregnancy
  • Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
  • Participation or planning to participate in another clinical trial during the same period
  • Refusal to comply with the study protocol

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PCI using stenting or balloon expansion
Opening single CTO lesions using drug-eluting stents (such as Xience V and Prime, Endeavor Resolute, Taxus express and Libete, Excel, Partner, BUMA, YINYI, TIVOLI,Firebird2,FireHawk, and Coroflex) or balloon expansion plus optimal medical therapy. Intravascular ultrasound (IVUS),optimal coherence tomgraphy (OCT) or fractional flow reserve (FFR) is used if they are needed. Optimal medical therapy includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-angina therapy should be used if the patients have symptoms.
all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)
Other Names:
  • percutaneous coronary intervention
Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.
NO_INTERVENTION: Optimal medical therapy
Optimal medical therapy. It includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes to myocardial viability
Time Frame: 12 months
Changes to myocardial viability from baseline assessed with the use of combined positron emission tomography and computerized tomography (PET-CT) system
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events
Time Frame: 12 months
including all-cause mortality, cardiac death, first or recurrent acute myocardial infarction, recurrent angina, target lesion revascularization (TLR), heart failure, and re-hospitalization
12 months
The rates of target vascular revascularization (TVR), TLR, and stent thrombosis
Time Frame: 12 months
12 months
Changes to left ventricular ejection fraction (LVEF)
Time Frame: 12 months
Changes to LVEF in % assessed with the use of cardiac MRI and transthoracic echocardiography (TTE).
12 months
Changes to myocardial infarct size
Time Frame: 12 months
Changes to myocardial infarct size in percentage of total myocardial size assessed with the use of cardiac MRI.
12 months
Changes to left ventricular mass (LVM)
Time Frame: 12 months
Changes to LVM in g assessed with the use of cardiac MRI.
12 months
Changes to cardiac output (CO)
Time Frame: 12 months
Changes to cardiac CO in in L/min/m2 assessed with the use of cardiac MRI.
12 months
Changes to stroke volume (SV)
Time Frame: 12 months
Changes to SV in ml assessed with the use of cardiac MRI.
12 months
Changes to maximum left ventricular ejection rate
Time Frame: 12 months
Changes to maximum left ventricular ejection rate in % assessed with the use of cardiac MRI.
12 months
Changes to maximum left ventricular filling rate
Time Frame: 12 months
Changes to maximum left ventricular filling rate in % assessed with the use of cardiac MRI.
12 months
Changes to maximum slope
Time Frame: 12 months
Changes to maximum slope assessed with the use of cardiac MRI.
12 months
Changes to left ventricular end-diastolic diameter (LVEDd)
Time Frame: 12 months
Changes to LVEDd in mm assessed with the use of TTE.
12 months
Changes to left ventricular end-systolic diameter (LVESd)
Time Frame: 12 months
Changes to LVESd in mm assessed with the use of TTE.
12 months
Changes to cardiac systolic function
Time Frame: 12 months
Changes to cardiac systolic function in E/A, E'/A', Ea/Aa, EDT in ms assessed with the use of TTE.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke incidence
Time Frame: 12 months
12 months
The number of compliant patients
Time Frame: 12 months
Compliant patients are usually defined as those who take predefined percentage (100%) of the treatment
12 months
The total cost of medical care
Time Frame: 12 months
The total cost of medical care include equipment and medication in dollars.
12 months
Number of guidewires
Time Frame: 12 months
Number of guidewires used in the procedure
12 months
Number of balloons
Time Frame: 12 months
Number of balloons used in the procedure
12 months
Number of stents
Time Frame: 12 months
Number of stents used in the procedure
12 months
the volume of contrast
Time Frame: 12 months
the volume of contrast in ml during the procedure
12 months
type of device
Time Frame: 12 months
type of the first guidewire and the final guidewire to cross the proximal lesion such as shaping ribbon or core-to-tip, coil or polymer Cover, hydrophilic coating or hydrophobic coating, and the new devices including Guidezilla™, CrossBoss™ , Tornus, Transporter and Stingray™, any other newest device which will be used before this study is completed.
12 months
the composite number of special techniques used in the procedure
Time Frame: 12 months
the special techniques including parallel wire, see-saw technique, side branch technique, STAR (subintimal tracking and reentry), intravascular ultrasound guiding wire, reverse-controlled antegrade and retrograde subintimal tracking (CART) technique and reverse CART technique.
12 months

Collaborators and Investigators

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

Publications and helpful links

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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 (ACTUAL)

September 15, 2015

Primary Completion (ACTUAL)

August 15, 2018

Study Completion (ACTUAL)

December 15, 2018

Study Registration Dates

First Submitted

October 18, 2015

First Submitted That Met QC Criteria

May 9, 2016

First Posted (ESTIMATE)

May 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 17, 2019

Last Verified

March 1, 2018

More Information

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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