Risk Factors and Outcomes in Coronary Chronic Total Occlusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
This study aims to assess the risk factors and evaluate the long-term outcomes of patients with coronary chronic total occlusion (CTO) treated with percutaneous coronary intervention or medical treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years; Patients with angina or silent ischemia and documented ischemia; Patients with CTO ≥ 3months
Disqualifiers
eGFR<15mL/(min·1.73m2); Chronic heart failure with NYHA grade ≥3; Had a history of coronary artery bypass grafting; Had received a percutaneous coronary intervention within the prior 3 months; Malignant tumor or immune system disorders; Pulmonary heart disease
Trial population
Patients with coronary artery disease and CTO undergone coronary angiography at Ruijin Hospital, Shanghai, China will be consecutively enrolled.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Coronary angiography
Procedure/Surgery
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: Patients with good coronary collaterals1 intervention
Group B: Patients with poor coronary collaterals1 intervention
Trial outcomes
Primary outcomes
1
The degree of collateral estimated visually by Rentrop score during coronary angiography
The degree of coronary collateralization supplying the distal area of the total coronary occlusion was visually graded using the Rentrop scoring system as follows: 0=no visible collaterals; 1=poorly opacified collaterals with faint visualization of the distal vessel; 2=partial filling of the collateral vessels; and 3=complete filling of the collateral vessels. Patients were then classified as poor coronary collaterals (Rentrop scores of 0 and 1) or good coronary collaterals (Rentrop scores of 2 and 3), according to the Rentrop score.
Time frame
Immediate post-angiography2
Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization
Time frame
up to 5 yearsSecondary outcomes
1
Event of all-cause mortality
Time frame
up to 5 years2
Event of death from cardiac causes
Time frame
up to 5 years3
Event of heart failure
Time frame
up to 5 years4
The change of left ventricular ejection fraction
Time frame
1 yearOther outcomes
1
The level of serum markers and biochemical indexes which have been reported to closely related to cardiovascular diseases and collateral formation.
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov