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Functional and Clinical Benefits of PCI in Patients With CTO

NCT ID: NCT01254253

Last Updated: 2011-11-22

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Function Quality of Life

Keywords

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percutaneous coronary intervention chronic total occlusion coronary angiography single photon emission CT Multislice coronary CT angiography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group a

no severe cardiac perfusion defects

Group Type EXPERIMENTAL

Percutaneous coronary intervention, PCI

Intervention Type DEVICE

PCI was performed using standard techniques for CTO.

Gooup b

reversible cardiac perfusion defects

Group Type EXPERIMENTAL

Percutaneous coronary intervention, PCI

Intervention Type DEVICE

PCI was performed using standard techniques for CTO.

Group c

irreversible cardiac perfusion defects

Group Type EXPERIMENTAL

Percutaneous coronary intervention, PCI

Intervention Type DEVICE

PCI was performed using standard techniques for CTO.

Interventions

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Percutaneous coronary intervention, PCI

PCI was performed using standard techniques for CTO.

Intervention Type DEVICE

Other Intervention Names

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Effect Xijing Hospital, Fourth Military Medical University

Eligibility Criteria

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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.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Feng Cao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

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Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongdong Sun, MD, PhD

Role: CONTACT

Phone: 86 13572242509

Email: [email protected]

Facility Contacts

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Dongdong Sun, MD, PhD

Role: primary

Other Identifiers

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EFFECT

Identifier Type: -

Identifier Source: org_study_id