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Hibernation, MyocardialPhase 4NCT02767401

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

A Phase 4 study testing stenting or balloon expansion and aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc in people with Hibernation, Myocardial and Complete Occlusion of Coronary Artery, run by The First Affiliated Hospital of Dalian Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
stenting or balloon expansion and aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
15 Sep 2015to 15 Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

About this study

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.

Read the 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.

Being tested
stenting or balloon expansion, aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc
Keywords
PET-CT, Cardiac magnetic resonance (CMR) imaging, Major adverse cardiac events (MACEs), coronary artery disease
Medical subject headings
Myocardial Stunning, Cardiovascular Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stenting or balloon expansionDevice

    Also called percutaneous coronary intervention

    all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)

  • aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betalocDrug

    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.

Study groups in NCT02767401
Study groupRoleWhat they receive
PCI using stenting or balloon expansionActive comparatorOpening 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.
Receives: Device: stenting or balloon expansion; Drug: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc
Optimal medical therapyNo interventionOptimal 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes to myocardial viability

    Changes to myocardial viability from baseline assessed with the use of combined positron emission tomography and computerized tomography (PET-CT) system

    Measured: 12 months

Secondary outcomes (13)

  1. Major adverse cardiac events

    including all-cause mortality, cardiac death, first or recurrent acute myocardial infarction, recurrent angina, target lesion revascularization (TLR), heart failure, and re-hospitalization

    Measured: 12 months

  2. The rates of target vascular revascularization (TVR), TLR, and stent thrombosis

    Measured: 12 months

  3. Changes to left ventricular ejection fraction (LVEF)

    Changes to LVEF in % assessed with the use of cardiac MRI and transthoracic echocardiography (TTE).

    Measured: 12 months

  4. Changes to myocardial infarct size

    Changes to myocardial infarct size in percentage of total myocardial size assessed with the use of cardiac MRI.

    Measured: 12 months

  5. Changes to left ventricular mass (LVM)

    Changes to LVM in g assessed with the use of cardiac MRI.

    Measured: 12 months

  6. Changes to cardiac output (CO)

    Changes to cardiac CO in in L/min/m2 assessed with the use of cardiac MRI.

    Measured: 12 months

  7. Changes to stroke volume (SV)

    Changes to SV in ml assessed with the use of cardiac MRI.

    Measured: 12 months

  8. Changes to maximum left ventricular ejection rate

    Changes to maximum left ventricular ejection rate in % assessed with the use of cardiac MRI.

    Measured: 12 months

  9. Changes to maximum left ventricular filling rate

    Changes to maximum left ventricular filling rate in % assessed with the use of cardiac MRI.

    Measured: 12 months

  10. Changes to maximum slope

    Changes to maximum slope assessed with the use of cardiac MRI.

    Measured: 12 months

  11. Changes to left ventricular end-diastolic diameter (LVEDd)

    Changes to LVEDd in mm assessed with the use of TTE.

    Measured: 12 months

  12. Changes to left ventricular end-systolic diameter (LVESd)

    Changes to LVESd in mm assessed with the use of TTE.

    Measured: 12 months

  13. Changes to cardiac systolic function

    Changes to cardiac systolic function in E/A, E'/A', Ea/Aa, EDT in ms assessed with the use of TTE.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2016 (estimated)
  2. Study start15 Sep 2015
  3. Primary completion15 Aug 2018
  4. Study completion15 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02767401
Sponsor's protocol ID
LCKY2015-22
Status last verified
Mar 2018
First submitted
18 Oct 2015
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Namazi M, Safi M, Vakili H, Saadat H, Alipour S, Mahjoob P, Taherkhani M, Pedari S, Taherion M, Rajabi Moghaddam H, Alhazifi A, Vatanparast M, Khaligh S. Evaluation of effective factors in success rate of intervention on CTO. Acta Med Iran. 2015;53(3):173-6.

    PubMed 25796024

  • Stuijfzand WJ, Raijmakers PG, Driessen RS, van Royen N, Nap A, van Rossum AC, Knaapen P. Value of Hybrid Imaging with PET/CT to Guide Percutaneous Revascularization of Chronic Total Coronary Occlusion. Curr Cardiovasc Imaging Rep. 2015;8(7):26. doi: 10.1007/s12410-015-9340-2.

    PubMed 26029338

  • Lee SH, Yang JH, Choi SH, Song YB, Hahn JY, Choi JH, Kim WS, Lee YT, Gwon HC. Long-Term Clinical Outcomes of Medical Therapy for Coronary Chronic Total Occlusions in Elderly Patients (>/=75 Years). Circ J. 2015;79(8):1780-6. doi: 10.1253/circj.CJ-15-0041. Epub 2015 May 28.

    PubMed 26017064

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing stenting or balloon expansion and aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc in people with Hibernation, Myocardial and Complete Occlusion of Coronary Artery, run by The First Affiliated Hospital of Dalian Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes to myocardial viability (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02767401, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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