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

October 2, 2017 updated by: Genshan Ma, Southeast University, China

Ultrasonic Cardiogram to Evaluate the Long-term Outcome and Prognosis of Coronary Artery Chronic Total Occlusions for Percutaneous Revascularization Versus Optimal Medical Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.)

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • 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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital
        • Contact:
          • Weibing Shi, B.

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

coronary artery of chronic total occlusion

Exclusion Criteria:

ACS in 3months; once PCI or CABG; AF

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: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: recanalisation CTO lesion successful
Patients with CTO lesion performed PCI strategy and successfully recanalisation the CTO lesion with implanted stents .
Device: stent
PTCA or PCI
Other Names:
  • Balloon
NO_INTERVENTION: recanalisation CTO lesion failure
Patients with CTO lesion performed PCI strategy and failure recanalisation the CTO lesion with PCI wire and balloon..
NO_INTERVENTION: OMT
Patients with CTO lesion optimal medicine treatment without PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac death,
Time Frame: postoperation 1year
patients with CTO postoperative sudden death cause for acute myocardial infarction or severe arrhythmia
postoperation 1year
MACE
Time Frame: postoperation 1year
recurrent severe angina, revascularization
postoperation 1year

Collaborators and Investigators

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

Sponsor

Southeast University, China

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)

October 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

October 1, 2018

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (ACTUAL)

October 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014ZDSYLL120.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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