Functional and Clinical Benefits of PCI in Patients With CTO

Quality of Life Clinical Trial

Official title:

Multimodality Imaging Evaluation of Functional and Clinical Benefits of Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion Lesion

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01254253
• Other study ID #: EFFECT
• Status: Unknown status
• Phase: N/A
• First received: December 1, 2010
• Last updated: November 21, 2011
• Start date: October 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Xijing Hospital
• Contact: Dongdong Sun, MD, PhD
• Phone: 86 13572242509
• Email: wintersun3[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the diagnostic accuracy of hybrid imaging combining CTCA with low-dose stress-only SPECT vs. coronary angiography for detecting haemodynamic relevant coronary lesions; and second to determine the effects of PCI on cardiac perfusion, cardiac function and quality of life in patients with CTO lesion in left anterior descending (LAD) coronary artery.

Description:

Noninvasive imaging modalities have shown high diagnostic accuracy in the detection of coronary artery lesions, and for the estimation of their hemodynamic relevance.Thus, noninvasive assessment of myocardial perfusion defects may be preferred for patients with chronic total occlusion (CTO).

In particular, myocardial perfusion is measured with single photon emission CT (SPECT).Multislice coronary CT angiography (CCTA) with dual-source scanners reveals the anatomic location of coronary artery disease (CAD). These two techniques assess distinct aspects of heart morphology and function parameters of the heart, and should therefore be regarded as complementary rather than competing methods.Taking this into consideration, decisions regarding whether invasive revascularization therapy is adequate or not and which strategy is the best for long-term survival cannot be supported by anatomic information alone. Therefore, noninvasive complementary imaging of structure and perfusion, in conjunction with three-dimensional (3D) image fusion, has emerged as a technique for reliable allocation of perfusion defects to their supplying coronary artery.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: November 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• Patients were eligible for enrolment in this study if coronary angiography showed a CTO (at least for 3 months and confirmed by angiography and/or history of earlier MI).

Exclusion Criteria:

• Hypersensitivity to iodinated contrast agent, cardiomyopathy, non-sinus rhythm, severe valvular heart disease, NYHA functional class IV heart failure at baseline, previous coronary bypass surgery, renal insufficiency, severe lung and liver disease or cancer.

Related Conditions & MeSH terms

• Heart Function
• Quality of Life

Intervention

Device:
• Percutaneous coronary intervention, PCI
PCI was performed using standard techniques for CTO.

Locations

Country	Name	City	State
China	Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction		2year
Secondary	cardiac death		2year
Secondary	Non-fatal myocardial infarction		2 year
Secondary	Target lesion revascularization		2 year
Secondary	Angina pectoris score index		2 year
Secondary	Six-minute walk distance		2 year