The Success of Opening Concurrent CTO leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease

NCT03372785 | Unknown

• 1 other identifier: SOS-moral
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on cardiac function in multi-vessel disease patients with concurrent chronic total occlusion (CTO) lesion.

Conditions

Chronic Total Occlusion of Coronary Artery; Percutaneous Coronary Intervention; Coronary Artery Disease; Viable Myocardium

Keywords

Chronic total coronary artery occlusion; multi-vessel coronary artery disease; Percutaneous coronary intervention; coronary artery disease; cardiac function

Outcome Measures

Primary Outcomes (1)

• Changes of left ventricular ejection fraction (LVEF)

  Changes of LVEF, LVEDV, and LVESV assessed with the use of cardiac MRI.

  12 months

Secondary Outcomes (5)

• Major adverse cardiac events

  1, 6, and 12 months post-PCI

• Myocardial viability

  12 months post-PCI

• Quality of life changes

  1, 6, and 12-month follow-up

• Contrast used

  during the procedure

• Total cost of medical care

  from the day of enrollment (first hospitalization) to the last follow-up (rehospitalization)

Other Outcomes (1)

• Safety endpoints

  perioperative period

Study Arms (2)

Complete revascularization group

Complete Revascularization of CTO and non-CTO lesions

Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. stents or coronary balloons

Non-CTO revascularization group

Non-CTO vessel revascularization

Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. stents or coronary balloons

Interventions

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor DRUG

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.

Also known as: Optimal medical therapy

Complete revascularization group; Non-CTO revascularization group

coronary wires. stents or coronary balloons DEVICE

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

Also known as: percutaneous coronary intervention

Complete revascularization group; Non-CTO revascularization group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients should be 18-80 years old; be diagnosed with single CTO concurrent with MVD detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis); present with an LVEF above 35% determined using transthoracic echocardiography; present with CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm; and comply all the evaluations and follow-up protocols

You may qualify if:

• Patients should be 18-80 years old; be diagnosed with single CTO concurrent with MVD detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis); present with an LVEF above 35% determined using transthoracic echocardiography; present with CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm; and comply all the evaluations and follow-up protocols.

You may not qualify if:

• Patients will be excluded if they have suffered from acute myocardial infarction within the previous 3 months; a lesion located in the left main artery (stenosis ≥50%); rheumatic valvular disease; severe arrhythmia; a history of revascularization within the non-CTO artery; multiple vessels with CTO (more than one CTO artery); lesions unsuitable for PCI; severely abnormal hematopoietic systems, such as platelet counts \<100 x 109/L or \> 700 x 109/L and white blood cell counts \< 3 x 109/L; with active bleeding or bleeding tendencies (active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency); severe coexisting conditions, including severe renal function dysfunction \[Glomerular filtration rate (GFR) less than 60 ml/min • 1.73 m2), severe hepatic dysfunction \[glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference\], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders; tumors; surgery within 3 months; a life expectancy less than 12 months; pregnancy or planning to become pregnant; history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents. Patients will also be excluded if they cannot tolerate dual antiplatelet treatment (DAPT); are unable to communicate due to cognitive impairment, auditory, or visual impairment; are participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Metoprolol; Atorvastatin; Rosuvastatin Calcium; Clopidogrel; Ticagrelor; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Ticlopidine; Thienopyridines; Thiophenes; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Xiantao Song, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 14, 2017
• Study Start: April 10, 2018
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

CN (1)