Ultrasonic Cardiogram Evaluate the Prognosis of Percutaneous Revascularization of Chronic Total Occlusions

NCT ID: NCT03300011

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-10-01

Brief Summary

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Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing coronary angiography. The presence of an untreated CTO has been related to adverse clinical prognosis, both in stable angina and acute myocardial infarction, and is often associated with persistent symptomatic angina. Depending on their symptomatic and functional status as well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy combined with coronary revascularization. This study designed to evaluate the safety and efficacy of coronary chronic total occlusion PCI by ultrasonic cardiogram.

Detailed Description

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UCEPPCIOCT maintains a prospective clinical registry of all individual who undergo cardiac angiography,PCI or optimistic medicine treatment.

1\. research objective to observe the changes of cardiac function postoperative PCI in patients with CTO and the incidence of major adverse cardiovascular events, and provide the reality basis for PCI strategy in clinical patients with CTO . 2. research content: follow up the patients with CTO by using echocardiography in preoperative and postoperative PCI in 1m, 3ms, 6ms, 12ms to assess the changes of cardiac structure and cardiac function. 2, comparison the 'incidence of major adverse cardiovascular events undergo PCI treatment in success and failure group in patients with CTO (such as severe angina attack, severe acute coronary syndrome, severe heart failure should be rehospitalized , fatal arrhythmia and sudden cardiac death, etc.)

Conditions

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Coronary Chronic Total Occlusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
masking for Ultrasonic Cardiogram investigator

Study Groups

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recanalisation CTO lesion successful

Patients with CTO lesion performed PCI strategy and successfully recanalisation the CTO lesion with implanted stents .

Group Type EXPERIMENTAL

stent

Intervention Type DEVICE

PTCA or PCI

recanalisation CTO lesion failure

Patients with CTO lesion performed PCI strategy and failure recanalisation the CTO lesion with PCI wire and balloon..

Group Type NO_INTERVENTION

No interventions assigned to this group

OMT

Patients with CTO lesion optimal medicine treatment without PCI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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stent

PTCA or PCI

Intervention Type DEVICE

Other Intervention Names

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Balloon

Eligibility Criteria

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Inclusion Criteria

coronary artery of chronic total occlusion

Exclusion Criteria

ACS in 3months; once PCI or CABG; AF
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Genshan Ma

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chen Lijuan, Ph.D

Role: CONTACT

15295583256

Ma Genshan, Ph.D

Role: CONTACT

13002580569

Facility Contacts

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Weibing Shi, B.

Role: primary

Other Identifiers

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2014ZDSYLL120.1

Identifier Type: -

Identifier Source: org_study_id