NCT01254253

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

1.4 years

First QC Date

December 1, 2010

Last Update Submit

November 21, 2011

Conditions

Heart FunctionQuality of Life

Keywords

percutaneous coronary interventionchronic total occlusioncoronary angiographysingle photon emission CTMultislice coronary CT angiography

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    2year

Secondary Outcomes (5)

  • 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

Study Arms (3)

Group a

EXPERIMENTAL

no severe cardiac perfusion defects

Device: Percutaneous coronary intervention, PCI

Gooup b

EXPERIMENTAL

reversible cardiac perfusion defects

Device: Percutaneous coronary intervention, PCI

Group c

EXPERIMENTAL

irreversible cardiac perfusion defects

Device: Percutaneous coronary intervention, PCI

Interventions

Percutaneous coronary intervention, PCIDEVICE

PCI was performed using standard techniques for CTO.

Also known as: Effect, Xijing Hospital, Fourth Military Medical University
Gooup bGroup aGroup c

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Interventions

Percutaneous Coronary InterventionTreatment Outcome

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresPrognosisDiagnosisOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Feng Cao, MD, PhD

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongdong Sun, MD, PhD

CONTACT

86 13572242509wintersun3@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 6, 2010

Study Start

October 1, 2008

Primary Completion

March 1, 2010

Study Completion

November 1, 2011

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

CN(1)