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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03229993
Other study ID # OCT-20170723
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 31, 2017
Est. completion date December 31, 2019

Study information

Verified date July 2020
Source The First Affiliated Hospital with Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis.

It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date December 31, 2019
Est. primary completion date January 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT.

Exclusion Criteria:

- Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions.

Study Design


Related Conditions & MeSH terms

  • Borderline Coronary Artery Lesions
  • Coronary Angiography (CAG)
  • Optical Coherence Tomography (OCT)
  • Percutaneous Coronary Intervention (PCI)
  • Single-Photon Emission Computed Tomography (SPECT)

Intervention

Diagnostic Test:
OCT
OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions

Locations

Country Name City State
China First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary MACEs The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis. 12 months
Primary TLR The incidence of target lesion revascularization (TLR) 12 months
Secondary Rehospitalization The incidence of rehospitalization due to cardiac events 12 months
Secondary Recurrent angina The incidence of recurrent angina 12 months
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