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Functional and Clinical Benefits of PCI in Patients With CTO

This study is currently recruiting participants.
Verified November 2011 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01254253
First received: December 1, 2010
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Heart Function
Quality of Life
 Device: Percutaneous coronary intervention, PCI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multimodality Imaging Evaluation of Functional and Clinical Benefits of Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion Lesion

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: 2year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiac death [ Time Frame: 2year ] [ Designated as safety issue: Yes ]
  • Non-fatal myocardial infarction [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Angina pectoris score index [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Six-minute walk distance [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2008
Estimated Study Completion Date: November 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group a
no severe cardiac perfusion defects
 Device: Percutaneous coronary intervention, PCI
PCI was performed using standard techniques for CTO.
Other Names:
  • Effect
  • Xijing Hospital, Fourth Military Medical University
Experimental: Gooup b
reversible cardiac perfusion defects
 Device: Percutaneous coronary intervention, PCI
PCI was performed using standard techniques for CTO.
Other Names:
  • Effect
  • Xijing Hospital, Fourth Military Medical University
Experimental: Group c
irreversible cardiac perfusion defects
 Device: Percutaneous coronary intervention, PCI
PCI was performed using standard techniques for CTO.
Other Names:
  • Effect
  • Xijing Hospital, Fourth Military Medical University

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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254253

Contacts
Contact: Dongdong Sun, MD, PhD 86 13572242509 wintersun3@gmail.com

Locations
China, Shaanxi
Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Dongdong Sun, MD, PhD     86 13572242509     wintersun3@gmail.com    
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Feng Cao, MD, PhD Xijing Hospital, Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01254253     History of Changes
Other Study ID Numbers: EFFECT
Study First Received: December 1, 2010
Last Updated: November 21, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
percutaneous coronary intervention
chronic total occlusion
coronary angiography
single photon emission CT
Multislice coronary CT angiography

ClinicalTrials.gov processed this record on May 23, 2013