Prognostic Value of CT dynamIc Myocardial Perfusion in Pa... | NCT03250455

Studies
Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis

NCT03250455

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Aug 15, 2017Actual

Enrollment

1,748Estimated

Phase

Not provided

Conditions

CT Perfusion

Interventions

CTA CTP
CTA

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2017Estimated

Primary Completion Date

Nov 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Aug 10, 2017

First Submission Date that Met QC Criteria

Aug 10, 2017

First Posted Date

Aug 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2017

Last Update Posted Date

Aug 15, 2017Actual

Name	Class
Peking Union Medical College Hospital	OTHER
Shanghai Jiao Tong University Affiliated Sixth People's Hospital	OTHER
Guangdong Provincial People's Hospital	OTHER

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,748Estimated

Label	Type	Description	Intervention Names
CTA+CTP			Diagnostic Test: CTA CTP
CTA only			Diagnostic Test: CTA

Name	Type	Description	Arm Group Labels	Other Names
CTA CTP	Diagnostic Test	CT Angiography myocardial CT Perfusion	CTA+CTP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	death, myocardial infarction and unstable angina requiring hospitalization	90 days, 6 months, 12 months, 24 months and 36 months

Secondary Outcomes

Measure	Description	Time Frame
invasive coronary angiography and revascularization	invasive coronary angiography and PCI or CABG	90 days, 6 months, 12 months, 24 months and 36 months
he incidence of a composite of major complications from cardiovascular procedures and testing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥18 years.
stable chest pain with obstructive coronary stenosis (50-90%) assessed by CTA.

Exclusion Criteria:

(1) Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB).

(2) Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy.

(3) Known CAD with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG).

(4) Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms.

(5) Contraindication to undergoing CTA, including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers, c. creatinine ≥1.7 mg/dl or GFR≤30 ml/min , d. Pregnancy.

(6) Contraindication to ATP, including but not limited to: a. II or III atrioventricular block, b. bronchial asthma, c. hypotension (SBP<90mmHg), d. bronchial stenosis or bronchospasm, e. acute myocardial infarction, f. left main stenosis, g. unstable angina, h. allergy to aminophylline.

(7) Life expectancy < 2 years. (8) Unable to provide written informed consent or participate in long-term follow-up.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with stable chest pain and diagnosed of obstructive coronary stenosis (50-90%) by CTA were enrolled.

Sampling Method

Probability Sample