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

Coronary Chronic Total Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03300011
• Other study ID #: 2014ZDSYLL120.1
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2017
• Last updated: October 2, 2017
• Start date: October 1, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: September 2017
• Source: Southeast University, China
• Contact: Chen Lijuan, Ph.D
• Phone: 15295583256
• Email: chenlijuan[@]seu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

coronary artery of chronic total occlusion

Exclusion Criteria:

ACS in 3months; once PCI or CABG; AF

Related Conditions & MeSH terms

• Coronary Chronic Total Occlusion

Intervention

Device:
• stent
PTCA or PCI

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac death,	patients with CTO postoperative sudden death cause for acute myocardial infarction or severe arrhythmia	postoperation 1year
Primary	MACE	recurrent severe angina, revascularization	postoperation 1year