Functional and Clinical Benefits of PCI in Patients With CTO

NCT01254253 — Not applicable, Unknown, 150 participants, Xijing Hospital

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

Registry	NCT01254253
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	150 (Estimated)
Sponsor	Xijing Hospital (Other)
Conditions	Heart Function, Quality of Life
Interventions	Percutaneous coronary intervention, PCI (Device)
Dates	start 2008-10-01, primary completion 2010-03-01, completion 2011-11-01 (estimated), first posted 2010-12-06, last updated 2011-11-22
Locations	1 site in China

-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.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Group a	Experimental	Device: Percutaneous coronary intervention, PCI	no severe cardiac perfusion defects
Gooup b	Experimental	Device: Percutaneous coronary intervention, PCI	reversible cardiac perfusion defects
Group c	Experimental	Device: Percutaneous coronary intervention, PCI	irreversible cardiac perfusion defects

Percutaneous coronary intervention, PCI (Device), also known as Effect, Xijing Hospital, Fourth Military Medical University: PCI was performed using standard techniques for CTO.

+Outcome measures

Primary outcomes

Left ventricular ejection fraction [2year]

Secondary outcomes

cardiac death [2year]
Non-fatal myocardial infarction [2 year]
Target lesion revascularization [2 year]
Angina pectoris score index [2 year]
Six-minute walk distance [2 year]

+Eligibility

Sex: All, ages: any to 70 Years

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.

+Locations (1)

Facility	City	Country	Status
Fourth Military Medical University	Xi'an, Shaanxi	China	Recruiting

+Investigators

Feng Cao, MD, PhD, Principal investigator, Air Force Military Medical University, China