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

NCT ID: NCT03250455

Last Updated: 2017-08-15

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

Total Enrollment

1748 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-31

Study Completion Date

2020-12-31

Brief Summary

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VALIDITY is a prospective, open-label, multicenter, randomized controlled trial (ClinicalTrials.gov number). The study was designed to evaluate the value of noninvasive anatomic CTA combined with functional CTP for the next clinical decision making and the added prognostic value of CTP beyond CTA.

Detailed Description

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Conditions

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CT Perfusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CTA+CTP

CTA CTP

Intervention Type DIAGNOSTIC_TEST

CT Angiography myocardial CT Perfusion

CTA only

CTA

Intervention Type DIAGNOSTIC_TEST

CT Angiography

Interventions

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CTA CTP

CT Angiography myocardial CT Perfusion

Intervention Type DIAGNOSTIC_TEST

CTA

CT Angiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. age ≥18 years.
2. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bin Lu

chief of Radilogy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bin Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Xiehe Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Shanghai Sixth People's Hospital

Shanghai, , China

Site Status RECRUITING

General hospital of tianjin medical university

Tianjin, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Yang Gao, MD

Role: CONTACT

86-10-88328651

Facility Contacts

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Bin Lu, MD

Role: primary

86-10-88322662

Yang Gao, MD

Role: backup

86-10-88322651

Yingning Wang, MD

Role: primary

86-10-13661003076

Lu Lin, MD

Role: backup

86-10-13520298919

Hui Liu, MD

Role: primary

8613580352002

Hui Gu, MD

Role: backup

86-0531-68776770

Jiayin Zhang, MD

Role: primary

86-20-18930173280

Jian Ma, MD

Role: backup

86-20-18930174762

Zhang Zhang, MD

Role: primary

15900388839

Dong Li, MD

Role: backup

15222709990

Other Identifiers

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CIFuwaiHospital-2

Identifier Type: -

Identifier Source: org_study_id

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